Pub Date : 2026-01-13DOI: 10.1186/s12885-026-15569-3
Madelaine Hettler, Josephine Kirschstein, Isabelle Ayx, Melissa Harbrücker, Franka Menge, Christoph Reißfelder, Stefan Schönberg, Dominik Nörenberg, Matthias F Froelich, Jens Jakob
Background: Accurate imaging plays a crucial role for prognostic assessment and treatment allocation in soft tissue sarcoma (STS). Guidelines recommend contrast-enhanced magnetic resonance imaging (MRI) including diffusion-weighted imaging (DWI) for tumor assessment. This study aims to evaluate the extent to which the MRI protocols used in clinical practice align with the sequences specified in the guideline in the diagnostic work-up of sarcoma patients.
Methods: We analyzed a cohort of patients treated at the Sarcoma Center of the University Medical Center Mannheim (UMM). Pretherapeutic MRI protocols were compared with the recommendations of the German sarcoma guideline.
Results: We analyzed 64 MRI examinations of patients with STS of the extremities and trunk, notably 62 performed at external radiology centers and 2 at UMM. A pretherapeutic contrast-enhanced MRI was available in 51 of 64 cases (79.7%), of which 40 referrals explicitly indicated a soft tissue tumor. In 3.1% of the cases, the complete set of guideline-recommended sequences was not performed. At least two of the required sequences were consistently available. The most frequently absent sequences were the T1-weighted sequence without fat saturation acquired before and after contrast administration using identical acquisition parameters (82.8%) and DWI sequences (78.1%).
Conclusions: MRI protocol selection is primarily guided by the clinical referral question. Our analysis indicates that a substantial proportion of examinations deviated from recommended protocols. Contributing factors may include inaccurate clinical referral questions, limited guideline awareness, reimbursement constraints in outpatient settings, or diagnostic considerations. Standardized imaging represents a key instrument for quality assurance in the diagnosis of STS and forms the foundation for clinical and translational studies. In the future, the recommendations should be re-evaluated and published in a clear, accessible format to ensure broad implementation.
{"title":"Evaluation of magnetic resonance imaging parameters and compliance with guidelines in soft tissue sarcomas.","authors":"Madelaine Hettler, Josephine Kirschstein, Isabelle Ayx, Melissa Harbrücker, Franka Menge, Christoph Reißfelder, Stefan Schönberg, Dominik Nörenberg, Matthias F Froelich, Jens Jakob","doi":"10.1186/s12885-026-15569-3","DOIUrl":"https://doi.org/10.1186/s12885-026-15569-3","url":null,"abstract":"<p><strong>Background: </strong>Accurate imaging plays a crucial role for prognostic assessment and treatment allocation in soft tissue sarcoma (STS). Guidelines recommend contrast-enhanced magnetic resonance imaging (MRI) including diffusion-weighted imaging (DWI) for tumor assessment. This study aims to evaluate the extent to which the MRI protocols used in clinical practice align with the sequences specified in the guideline in the diagnostic work-up of sarcoma patients.</p><p><strong>Methods: </strong>We analyzed a cohort of patients treated at the Sarcoma Center of the University Medical Center Mannheim (UMM). Pretherapeutic MRI protocols were compared with the recommendations of the German sarcoma guideline.</p><p><strong>Results: </strong>We analyzed 64 MRI examinations of patients with STS of the extremities and trunk, notably 62 performed at external radiology centers and 2 at UMM. A pretherapeutic contrast-enhanced MRI was available in 51 of 64 cases (79.7%), of which 40 referrals explicitly indicated a soft tissue tumor. In 3.1% of the cases, the complete set of guideline-recommended sequences was not performed. At least two of the required sequences were consistently available. The most frequently absent sequences were the T1-weighted sequence without fat saturation acquired before and after contrast administration using identical acquisition parameters (82.8%) and DWI sequences (78.1%).</p><p><strong>Conclusions: </strong>MRI protocol selection is primarily guided by the clinical referral question. Our analysis indicates that a substantial proportion of examinations deviated from recommended protocols. Contributing factors may include inaccurate clinical referral questions, limited guideline awareness, reimbursement constraints in outpatient settings, or diagnostic considerations. Standardized imaging represents a key instrument for quality assurance in the diagnosis of STS and forms the foundation for clinical and translational studies. In the future, the recommendations should be re-evaluated and published in a clear, accessible format to ensure broad implementation.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145958822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-13DOI: 10.1186/s12885-026-15565-7
Hailiang Zhang, Yukang Yang, Rong Li, Xueqi Bai, Xue Li, Xia Yan, Jianbo Song
Objectives: To develop and validate a prognostic nomogram incorporating clinical and nutritional factors for individualized survival prediction in elderly patients with inoperable esophageal squamous cell carcinoma (ESCC) treated with intensity-modulated radiotherapy (IMRT).
Methods: This retrospective study enrolled 300 patients aged over 65 with inoperable ESCC who underwent IMRT. Patients were randomly allocated to a training set (n = 211) and a validation set (n = 89) in a 7:3 ratio. Prognostic variables were initially screened using univariate Cox regression, followed by variable selection via the least absolute shrinkage and selection operator regression. Independent predictors were identified through multivariate Cox analysis and incorporated into a nomogram model. Model performance was evaluated using the concordance index, receiver operating characteristic curves, and calibration curves, with the model's discriminative ability further validated by Kaplan-Meier survival analysis.
Results: Four independent prognostic factors were identified: age ≥ 70 years (HR = 1.50, P = 0.019), Karnofsky performance status score ≥ 80 (HR = 0.54, P = 0.003), radiotherapy dose ≥ 58 Gy (HR = 0.53, P < 0.001), and serum albumin ≥ 40 g/L (HR = 0.70, P = 0.041). The nomogram demonstrated predictive ability for 2-year and 5-year overall survival (OS), with better predictive performance for 5-year OS. The area under the curve values in the training cohort were 0.732 and 0.681, while those in the validation cohort were 0.570 and 0.740, respectively. Calibration and decision curve analyses confirmed the clinical utility and accuracy of the model. Compared to the AJCC 8th edition TNM staging system, the nomogram exhibited superior long-term prognostic performance in this population.
Conclusion: This study proposes a clinical nomogram model to assist clinicians in predicting the survival of elderly patients with inoperable ESCC undergoing IMRT and formulating treatment plans.
{"title":"A prognostic nomogram for elderly patients with inoperable esophageal cancer undergoing intensity-modulated radiotherapy.","authors":"Hailiang Zhang, Yukang Yang, Rong Li, Xueqi Bai, Xue Li, Xia Yan, Jianbo Song","doi":"10.1186/s12885-026-15565-7","DOIUrl":"https://doi.org/10.1186/s12885-026-15565-7","url":null,"abstract":"<p><strong>Objectives: </strong>To develop and validate a prognostic nomogram incorporating clinical and nutritional factors for individualized survival prediction in elderly patients with inoperable esophageal squamous cell carcinoma (ESCC) treated with intensity-modulated radiotherapy (IMRT).</p><p><strong>Methods: </strong>This retrospective study enrolled 300 patients aged over 65 with inoperable ESCC who underwent IMRT. Patients were randomly allocated to a training set (n = 211) and a validation set (n = 89) in a 7:3 ratio. Prognostic variables were initially screened using univariate Cox regression, followed by variable selection via the least absolute shrinkage and selection operator regression. Independent predictors were identified through multivariate Cox analysis and incorporated into a nomogram model. Model performance was evaluated using the concordance index, receiver operating characteristic curves, and calibration curves, with the model's discriminative ability further validated by Kaplan-Meier survival analysis.</p><p><strong>Results: </strong>Four independent prognostic factors were identified: age ≥ 70 years (HR = 1.50, P = 0.019), Karnofsky performance status score ≥ 80 (HR = 0.54, P = 0.003), radiotherapy dose ≥ 58 Gy (HR = 0.53, P < 0.001), and serum albumin ≥ 40 g/L (HR = 0.70, P = 0.041). The nomogram demonstrated predictive ability for 2-year and 5-year overall survival (OS), with better predictive performance for 5-year OS. The area under the curve values in the training cohort were 0.732 and 0.681, while those in the validation cohort were 0.570 and 0.740, respectively. Calibration and decision curve analyses confirmed the clinical utility and accuracy of the model. Compared to the AJCC 8th edition TNM staging system, the nomogram exhibited superior long-term prognostic performance in this population.</p><p><strong>Conclusion: </strong>This study proposes a clinical nomogram model to assist clinicians in predicting the survival of elderly patients with inoperable ESCC undergoing IMRT and formulating treatment plans.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-12DOI: 10.1186/s12885-026-15558-6
Guo-Ming Zhang, Tao Wang, Bing Gu
Background: Serum cancer antigen 125 (CA-125) is widely used in the diagnosis and follow-up of ovarian cancer, but its reference interval may vary between populations. We aimed to establish sex- and age-specific reference intervals for serum CA-125 in healthy Han Chinese adults receiving routine health checks, following CLSI C28-A3 guidance.
Methods: We reviewed health-check records from Shuyang Hospital and identified 10,076 Han Chinese adults aged 18-90 years whose serum CA-125 concentration was measured between October 2018 and December 2023. Individuals with self-reported or clinically documented chronic diseases, acute infection, pregnancy or abnormal results in complete blood count, liver and renal function tests, fasting plasma glucose or C-reactive protein were excluded. Serum CA-125 was measured on a DxI 800 chemiluminescent immunoassay analyser (Beckman Coulter). Statistical outliers were identified within sex and age partitions via Tukey's rule and, where needed, the Dixon test. Reference limits and 90% confidence intervals were estimated according to CLSI recommendations.
Results: After applying the clinical and laboratory criteria and removing 170 statistical outliers, 9,871 apparently healthy Han adults (7,688 females and 2,183 males) remained for analysis. The upper reference limit for CA-125 in men was 19.7 U/mL. In women, CA-125 concentrations were higher than those in men and were negatively correlated with age (Spearman r = - 0.2488, P < 0.001). The upper reference limits were 33.1 U/mL for women aged 18-30 years, 28.1 U/mL for those aged 31-70 years and 21.8 U/mL for those aged 71-90 years.
Conclusions: Using a large health-check cohort and CLSI-based methodology, we established sex-specific and age-specific reference intervals for serum CA-125 in Han Chinese adults via the Beckman DxI 800 platform. In this population, CA-125 tends to decrease with age in women and remains relatively stable in men. These locally derived intervals may improve the interpretation of CA-125 in Han adults but should be verified in other centers, assay systems and ethnic groups.
{"title":"Establishing reference interval of serum CA-125 for the healthy Han population in China.","authors":"Guo-Ming Zhang, Tao Wang, Bing Gu","doi":"10.1186/s12885-026-15558-6","DOIUrl":"https://doi.org/10.1186/s12885-026-15558-6","url":null,"abstract":"<p><strong>Background: </strong>Serum cancer antigen 125 (CA-125) is widely used in the diagnosis and follow-up of ovarian cancer, but its reference interval may vary between populations. We aimed to establish sex- and age-specific reference intervals for serum CA-125 in healthy Han Chinese adults receiving routine health checks, following CLSI C28-A3 guidance.</p><p><strong>Methods: </strong>We reviewed health-check records from Shuyang Hospital and identified 10,076 Han Chinese adults aged 18-90 years whose serum CA-125 concentration was measured between October 2018 and December 2023. Individuals with self-reported or clinically documented chronic diseases, acute infection, pregnancy or abnormal results in complete blood count, liver and renal function tests, fasting plasma glucose or C-reactive protein were excluded. Serum CA-125 was measured on a DxI 800 chemiluminescent immunoassay analyser (Beckman Coulter). Statistical outliers were identified within sex and age partitions via Tukey's rule and, where needed, the Dixon test. Reference limits and 90% confidence intervals were estimated according to CLSI recommendations.</p><p><strong>Results: </strong>After applying the clinical and laboratory criteria and removing 170 statistical outliers, 9,871 apparently healthy Han adults (7,688 females and 2,183 males) remained for analysis. The upper reference limit for CA-125 in men was 19.7 U/mL. In women, CA-125 concentrations were higher than those in men and were negatively correlated with age (Spearman r = - 0.2488, P < 0.001). The upper reference limits were 33.1 U/mL for women aged 18-30 years, 28.1 U/mL for those aged 31-70 years and 21.8 U/mL for those aged 71-90 years.</p><p><strong>Conclusions: </strong>Using a large health-check cohort and CLSI-based methodology, we established sex-specific and age-specific reference intervals for serum CA-125 in Han Chinese adults via the Beckman DxI 800 platform. In this population, CA-125 tends to decrease with age in women and remains relatively stable in men. These locally derived intervals may improve the interpretation of CA-125 in Han adults but should be verified in other centers, assay systems and ethnic groups.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145958876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-12DOI: 10.1186/s12885-025-15183-9
Riccardo Guastella, Giampaolo Perri, Domenico Bassi, Nicola Canitano, Virginia Padoan, Samuele Grandi, Riccardo Pellegrini, Letizia Procaccio, Francesca Bergamo, Sara Lonardi, Riccardo Carandina, Enrico Gringeri, Giovanni Marchegiani, Umberto Cillo
Background: Pancreatic cancer oligometastatic to the liver represents a distinct subset of advanced disease, presenting a limited number of metastases in a single site. First-line chemotherapy is considered the standard of care, with a poor overall prognosis. However, the optimal strategy for oligometastatic patients presenting response or stability after treatment is unclear. In selected patients, surgical resection is associated with prolonged survival, according to retrospective series. The aim of this randomized clinical trial is to compare the efficacy and safety of surgery versus observation or continuation of chemotherapy in patients with resectable pancreatic cancer oligometastatic to the liver with stable disease or response after first-line chemotherapy.
Methods: The study is a phase-2 multicentric randomized controlled trial with 1:1 allocation ratio. Patients diagnosed with pancreatic cancer and a limited number (up to 3) of liver metastases, with no evidence of extrahepatic disease, who received systemic chemotherapy as the initial treatment and with disease response or stability after therapy will be considered eligible patients. Patients will be randomized to either Arm A (surgery) or Arm B (observation or continuation of chemotherapy). The primary outcome will be overall survival at two years, with secondary outcomes including progression-free survival, treatment-related adverse events, quality of life and translational analyses.
Discussion: This randomized controlled trial will evaluate the role of surgery in pancreatic cancer oligometastatic to the liver after response or stability to first-line chemotherapy. While systemic therapy remains the standard of care, selected patients may benefit from surgical resection. By comparing surgery to observation or continuation of chemotherapy, the SONAR trial aims to fill a critical gap in treatment strategies and potentially refine the management of this challenging disease.
Trial registration: The trial has been registered at ClinicalTrials.gov on 15/11/2024 before inclusion of the first patient (NCT06690528).
{"title":"Conversion surgery vs. standard of care in pancreaTic cancer oligometastatic to the liver (SONAR: Surgery in Oligometastatic paNcreatic cAnceR) a randomized controlled trial.","authors":"Riccardo Guastella, Giampaolo Perri, Domenico Bassi, Nicola Canitano, Virginia Padoan, Samuele Grandi, Riccardo Pellegrini, Letizia Procaccio, Francesca Bergamo, Sara Lonardi, Riccardo Carandina, Enrico Gringeri, Giovanni Marchegiani, Umberto Cillo","doi":"10.1186/s12885-025-15183-9","DOIUrl":"10.1186/s12885-025-15183-9","url":null,"abstract":"<p><strong>Background: </strong>Pancreatic cancer oligometastatic to the liver represents a distinct subset of advanced disease, presenting a limited number of metastases in a single site. First-line chemotherapy is considered the standard of care, with a poor overall prognosis. However, the optimal strategy for oligometastatic patients presenting response or stability after treatment is unclear. In selected patients, surgical resection is associated with prolonged survival, according to retrospective series. The aim of this randomized clinical trial is to compare the efficacy and safety of surgery versus observation or continuation of chemotherapy in patients with resectable pancreatic cancer oligometastatic to the liver with stable disease or response after first-line chemotherapy.</p><p><strong>Methods: </strong>The study is a phase-2 multicentric randomized controlled trial with 1:1 allocation ratio. Patients diagnosed with pancreatic cancer and a limited number (up to 3) of liver metastases, with no evidence of extrahepatic disease, who received systemic chemotherapy as the initial treatment and with disease response or stability after therapy will be considered eligible patients. Patients will be randomized to either Arm A (surgery) or Arm B (observation or continuation of chemotherapy). The primary outcome will be overall survival at two years, with secondary outcomes including progression-free survival, treatment-related adverse events, quality of life and translational analyses.</p><p><strong>Discussion: </strong>This randomized controlled trial will evaluate the role of surgery in pancreatic cancer oligometastatic to the liver after response or stability to first-line chemotherapy. While systemic therapy remains the standard of care, selected patients may benefit from surgical resection. By comparing surgery to observation or continuation of chemotherapy, the SONAR trial aims to fill a critical gap in treatment strategies and potentially refine the management of this challenging disease.</p><p><strong>Trial registration: </strong>The trial has been registered at ClinicalTrials.gov on 15/11/2024 before inclusion of the first patient (NCT06690528).</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"26 1","pages":"44"},"PeriodicalIF":3.4,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12794266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145958901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-12DOI: 10.1186/s12885-025-15519-5
Zhe Sun, Pengyu Tan, Sa Zhou, Wenjian Ma
Background: Sterol carrier protein 2 (SCP2) plays a critical role in intracellular lipid transport and metabolism across human tissues. The objective of this study was to perform a comprehensive pan-cancer analysis of SCP2, evaluating its expression, prognostic significance, and functional mechanisms.
Methods: We analyzed SCP2 expression using data from TCGA and GTEx databases. Prognostic significance was evaluated via Kaplan-Meier and Cox regression analyses, alongside nomogram construction. Functional mechanisms were investigated through GO, KEGG, and GSEA enrichment analyses. Genetic alterations, DNA methylation, single-cell functions, and immune infiltration were assessed using multiple bioinformatic platforms. The effects of SCP2 on cancer cell proliferation, migration, apoptosis, and sensitivity to ferroptosis were verified by in vitro experiments.
Results: SCP2 was differentially expressed in multiple tumors and correlated with clinical outcomes and immune infiltration. Enrichment analyses linked SCP2 to lipid metabolism-related pathways. In colon adenocarcinoma (COAD), SCP2 was downregulated and functioned as a tumor suppressor, as its overexpression inhibited proliferation and migration, promoted apoptosis, and strongly enhanced ferroptosis sensitivity in colon cancer cells.
Conclusion: Our pan-cancer analysis highlights the broad biological and clinical significance of SCP2. It functions as a tumor suppressor and key regulator of ferroptosis in COAD, highlighting its potential as a promising therapeutic target.
{"title":"Comprehensive pan-cancer analysis and experimental verification of the roles of SCP2 in colon adenocarcinoma.","authors":"Zhe Sun, Pengyu Tan, Sa Zhou, Wenjian Ma","doi":"10.1186/s12885-025-15519-5","DOIUrl":"https://doi.org/10.1186/s12885-025-15519-5","url":null,"abstract":"<p><strong>Background: </strong>Sterol carrier protein 2 (SCP2) plays a critical role in intracellular lipid transport and metabolism across human tissues. The objective of this study was to perform a comprehensive pan-cancer analysis of SCP2, evaluating its expression, prognostic significance, and functional mechanisms.</p><p><strong>Methods: </strong>We analyzed SCP2 expression using data from TCGA and GTEx databases. Prognostic significance was evaluated via Kaplan-Meier and Cox regression analyses, alongside nomogram construction. Functional mechanisms were investigated through GO, KEGG, and GSEA enrichment analyses. Genetic alterations, DNA methylation, single-cell functions, and immune infiltration were assessed using multiple bioinformatic platforms. The effects of SCP2 on cancer cell proliferation, migration, apoptosis, and sensitivity to ferroptosis were verified by in vitro experiments.</p><p><strong>Results: </strong>SCP2 was differentially expressed in multiple tumors and correlated with clinical outcomes and immune infiltration. Enrichment analyses linked SCP2 to lipid metabolism-related pathways. In colon adenocarcinoma (COAD), SCP2 was downregulated and functioned as a tumor suppressor, as its overexpression inhibited proliferation and migration, promoted apoptosis, and strongly enhanced ferroptosis sensitivity in colon cancer cells.</p><p><strong>Conclusion: </strong>Our pan-cancer analysis highlights the broad biological and clinical significance of SCP2. It functions as a tumor suppressor and key regulator of ferroptosis in COAD, highlighting its potential as a promising therapeutic target.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145958825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: Cancer of the breast is one of the most predominant types of cancer among women. Quality of life (QoL) is an important variable for cancer treatment and breast cancer. Most of the QoL instruments that have been developed and tested in western culture to measure QoL of women with breast cancer. Therefore, this study aimed to develop and validate a culturally specific tool to measure the QoL of Indian women with breast cancer.
Methods: A Delphi method was followed with 11 multi-professional healthcare professional working in the treatment and rehabilitation of breast cancer survivors to ensure content validity and consensus was defined as at least 80% agreement. The questionnaire (41 items) covered relevant topics on QoL in six domains; General Health, Physical Well-Being, Functional Well-Being, Emotional Well-Being, Family Well-Being and Social Well-Being.
Results: The expert panel's agreements served as the framework for the scale rating. The first round had a 100% participant response rate, with 36 of 41 items achieving 80% or more consensus and five items failing to meet this standard. In the second round, 37 items received ≥ 80% level of consensus with a further 4 gained agreements of ≤ 75%. Finally, the questionnaire was reduced to 34 assertions after an expert panel reviewed the statements for construction and content.
Conclusion: Creation of a QoL tool for breast cancer survivors suited to the culture is a significant advance in delivering tailored assistance and comprehension to individuals from a range of cultures. This tool fosters a more holistic and inclusive approach to treatment by embracing cultural nuances, improving the overall well-being and survivorship experience for breast cancer survivors.
{"title":"Development of culture specific quality of life tool for breast cancer survivors of Indian population.","authors":"Megha Peter, Narasimman Swaminathan, Pitchaimani Govindharaj","doi":"10.1186/s12885-026-15563-9","DOIUrl":"https://doi.org/10.1186/s12885-026-15563-9","url":null,"abstract":"<p><strong>Purpose: </strong>Cancer of the breast is one of the most predominant types of cancer among women. Quality of life (QoL) is an important variable for cancer treatment and breast cancer. Most of the QoL instruments that have been developed and tested in western culture to measure QoL of women with breast cancer. Therefore, this study aimed to develop and validate a culturally specific tool to measure the QoL of Indian women with breast cancer.</p><p><strong>Methods: </strong>A Delphi method was followed with 11 multi-professional healthcare professional working in the treatment and rehabilitation of breast cancer survivors to ensure content validity and consensus was defined as at least 80% agreement. The questionnaire (41 items) covered relevant topics on QoL in six domains; General Health, Physical Well-Being, Functional Well-Being, Emotional Well-Being, Family Well-Being and Social Well-Being.</p><p><strong>Results: </strong>The expert panel's agreements served as the framework for the scale rating. The first round had a 100% participant response rate, with 36 of 41 items achieving 80% or more consensus and five items failing to meet this standard. In the second round, 37 items received ≥ 80% level of consensus with a further 4 gained agreements of ≤ 75%. Finally, the questionnaire was reduced to 34 assertions after an expert panel reviewed the statements for construction and content.</p><p><strong>Conclusion: </strong>Creation of a QoL tool for breast cancer survivors suited to the culture is a significant advance in delivering tailored assistance and comprehension to individuals from a range of cultures. This tool fosters a more holistic and inclusive approach to treatment by embracing cultural nuances, improving the overall well-being and survivorship experience for breast cancer survivors.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-10DOI: 10.1186/s12885-026-15548-8
Blythe Adamson, Sascha van Boemmel-Wegmann, Elsie Horne, Sofia Soares, Qianyi Zhang, Lana Kovacevic, Nada Boualam, Rahul Somavanshi, Isabel Dorst, Arun Sujenthiran, Christoph Buhl
Background: High-quality real-world data (RWD) for oncology research remains limited in Germany despite significant clinical need. Electronic health record (EHR)-derived datasets offer potential to capture longitudinal clinical information, but their value depends on representativeness and data quality. We characterized EHR-derived oncology cohorts from Germany, evaluating alignment with national benchmarks and validating mortality endpoints for real-world evidence generation.
Methods: We analyzed deidentified EHR data from the Germany Flatiron Health Research Database comprising adult patients diagnosed with breast cancer, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) between 2016 and 2024. Demographic and clinical characteristics were compared to national benchmarks. Overall survival was estimated using Kaplan-Meier methods. We validated our composite mortality variable against German Cancer Registry data.
Results: The breast cancer cohort (n = 1,305, median age 58 years) included 75% early-stage disease, 80% invasive ductal carcinoma, 67% HR+/HER2-, and 19% triple-negative cases. The NSCLC cohort (n = 866, median age 69 years) comprised 49% stage IV disease, 73% non-squamous histology, and 16% EGFR-positive tumors among tested patients. The CRC cohort (n = 774, median age 67 years) included 31% stage IV disease with 90% receiving primary surgery. Cohort characteristics closely aligned with national benchmarks. Median overall survival from first-line therapy was 26.0 months (breast), 13.4 months (NSCLC), and 21.5 months (CRC). Mortality validation demonstrated 87.7% sensitivity and 91.7% specificity for vital status classification, with 98.8% temporal accuracy within 30 days.
Conclusions: German EHR-derived cancer cohorts are representative of national populations with validated mortality endpoints, supporting their use for robust real-world evidence generation in oncology research.
{"title":"Real-world evidence from Germany: representativeness analysis and mortality endpoint validation in electronic health record-derived oncology cohorts.","authors":"Blythe Adamson, Sascha van Boemmel-Wegmann, Elsie Horne, Sofia Soares, Qianyi Zhang, Lana Kovacevic, Nada Boualam, Rahul Somavanshi, Isabel Dorst, Arun Sujenthiran, Christoph Buhl","doi":"10.1186/s12885-026-15548-8","DOIUrl":"https://doi.org/10.1186/s12885-026-15548-8","url":null,"abstract":"<p><strong>Background: </strong>High-quality real-world data (RWD) for oncology research remains limited in Germany despite significant clinical need. Electronic health record (EHR)-derived datasets offer potential to capture longitudinal clinical information, but their value depends on representativeness and data quality. We characterized EHR-derived oncology cohorts from Germany, evaluating alignment with national benchmarks and validating mortality endpoints for real-world evidence generation.</p><p><strong>Methods: </strong>We analyzed deidentified EHR data from the Germany Flatiron Health Research Database comprising adult patients diagnosed with breast cancer, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) between 2016 and 2024. Demographic and clinical characteristics were compared to national benchmarks. Overall survival was estimated using Kaplan-Meier methods. We validated our composite mortality variable against German Cancer Registry data.</p><p><strong>Results: </strong>The breast cancer cohort (n = 1,305, median age 58 years) included 75% early-stage disease, 80% invasive ductal carcinoma, 67% HR+/HER2-, and 19% triple-negative cases. The NSCLC cohort (n = 866, median age 69 years) comprised 49% stage IV disease, 73% non-squamous histology, and 16% EGFR-positive tumors among tested patients. The CRC cohort (n = 774, median age 67 years) included 31% stage IV disease with 90% receiving primary surgery. Cohort characteristics closely aligned with national benchmarks. Median overall survival from first-line therapy was 26.0 months (breast), 13.4 months (NSCLC), and 21.5 months (CRC). Mortality validation demonstrated 87.7% sensitivity and 91.7% specificity for vital status classification, with 98.8% temporal accuracy within 30 days.</p><p><strong>Conclusions: </strong>German EHR-derived cancer cohorts are representative of national populations with validated mortality endpoints, supporting their use for robust real-world evidence generation in oncology research.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}