Pablo Berlanga, Isabelle Aerts, Nadège Corradini, Lee Aymar Ndounga-Diakou, Natacha Entz-Werle, Stéphane Ducassou, Nicolas André, François Sevrin, Pascal Chastagner, Chloe Puiseux, Morgane Cleirec, Dominique Plantaz, Emilie De Carli, Marion Gambart, Camille Khanfar, Sandrine Thouvenin, Arnaud Petit, Sébastien Klein, Claire Briandet, Frédéric Millot, Claire Pluchart, Yves Reguerre, Pascale Schneider, Jill Serre, Carine Halfon-Domenech, Liana Carausu, Christophe Piguet, Laure Saumet, Joy Benadiba, Samuel Abbou, Salim Laghouati, Birgit Geoerger, Gilles Vassal
{"title":"在真实世界的肿瘤研究中，研究者对放射学和功能成像报告进行集中审查：SACHA-法国经验","authors":"Pablo Berlanga, Isabelle Aerts, Nadège Corradini, Lee Aymar Ndounga-Diakou, Natacha Entz-Werle, Stéphane Ducassou, Nicolas André, François Sevrin, Pascal Chastagner, Chloe Puiseux, Morgane Cleirec, Dominique Plantaz, Emilie De Carli, Marion Gambart, Camille Khanfar, Sandrine Thouvenin, Arnaud Petit, Sébastien Klein, Claire Briandet, Frédéric Millot, Claire Pluchart, Yves Reguerre, Pascale Schneider, Jill Serre, Carine Halfon-Domenech, Liana Carausu, Christophe Piguet, Laure Saumet, Joy Benadiba, Samuel Abbou, Salim Laghouati, Birgit Geoerger, Gilles Vassal","doi":"10.1002/pbc.31449","DOIUrl":null,"url":null,"abstract":"<p><p>SACHA-France (NCT04477681) is a prospective real-world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off-label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.</p>","PeriodicalId":19822,"journal":{"name":"Pediatric Blood & Cancer","volume":" ","pages":"e31449"},"PeriodicalIF":2.4000,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience.\",\"authors\":\"Pablo Berlanga, Isabelle Aerts, Nadège Corradini, Lee Aymar Ndounga-Diakou, Natacha Entz-Werle, Stéphane Ducassou, Nicolas André, François Sevrin, Pascal Chastagner, Chloe Puiseux, Morgane Cleirec, Dominique Plantaz, Emilie De Carli, Marion Gambart, Camille Khanfar, Sandrine Thouvenin, Arnaud Petit, Sébastien Klein, Claire Briandet, Frédéric Millot, Claire Pluchart, Yves Reguerre, Pascale Schneider, Jill Serre, Carine Halfon-Domenech, Liana Carausu, Christophe Piguet, Laure Saumet, Joy Benadiba, Samuel Abbou, Salim Laghouati, Birgit Geoerger, Gilles Vassal\",\"doi\":\"10.1002/pbc.31449\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>SACHA-France (NCT04477681) is a prospective real-world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off-label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.</p>\",\"PeriodicalId\":19822,\"journal\":{\"name\":\"Pediatric Blood & Cancer\",\"volume\":\" \",\"pages\":\"e31449\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-11-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric Blood & Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pbc.31449\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Blood & Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pbc.31449","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience.
SACHA-France (NCT04477681) is a prospective real-world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off-label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.
期刊介绍：
Pediatric Blood & Cancer publishes the highest quality manuscripts describing basic and clinical investigations of blood disorders and malignant diseases of childhood including diagnosis, treatment, epidemiology, etiology, biology, and molecular and clinical genetics of these diseases as they affect children, adolescents, and young adults. Pediatric Blood & Cancer will also include studies on such treatment options as hematopoietic stem cell transplantation, immunology, and gene therapy.
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