Screening Circulating Tumor Cells as a Non-invasive Cancer Test in 1,585 Asymptomatic Adults (ICELLATE1)

Abstract

Cancer screening is an approach to reduce cancer-related morbidity and mortality rates. Among those screening tests that have been shown to lead to reduction in cancer deaths 2 tissue biomarkers, PSA and CA-125 have shown to contribute to clinical utility. No tumor marker has however been identified to date that is sufficiently sensitive or specific to be used on its own to screen for cancer. Screening for circulation tumor cells as a new biomarker in the blood therefore seems like an attractive possibility. Cancer is known to spread circulating tumor cells before symptoms occur. Therefore, we have screened 1,585 asymptomatic individuals of age 20 to 80 with no known cancer risk factors. 27 individuals showed one or more circulating tumor cell in a 7.5 ml blood sample, which constitutes a positive circulating tumor cell test, based on the iCellate IsoPicTM laboratory test. That number compares favourably with the cancer incidence of 157.1 per 100,000 people per year in Peru, given that the screening results would be expected to correspond to an accumulated incidence of up to 12 years. The present findings therefore identify circulating tumor cells as a promising new cancer screening test.