Colorectal Cancer Stage III Clinical Trial
Official title:
Epidemiological Study to Determine the Prevalence of ctDNA Positivity in Participants With Stage II (High Risk) or Stage III CRC After Surgery With Curative (R0) Intent and Subsequent Adjuvant Chemotherapy With Monitoring of ctDNA During Clinical Follow-up
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of 630 days thereafter, according to CRC stages and disease characteristics. Participants receive no therapeutic intervention as part of this study. This study will identify participants who might be potential candidates for the clinical trial BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard AdCTx in this patient population. Based on the eligibility criteria for that trial, this study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection and are therefore at high risk of disease recurrence to enrich the BNT122-01 study cohort. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that trial if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from BNT000-001 will be carried across to the BNT122-01 trial where feasible.
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