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 up to 630 days (21 months) thereafter, according to CRC stages and disease characteristics. Participants receive no therapeutic intervention as part of this study. This study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection who might be potential candidates for the clinical study BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard adjuvant chemotherapy in this patient population. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that study if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from this study (BNT000-001) will be carried across to the BNT122-01 study where feasible.
Individual participants will be involved in the study for at least 12 months to up to 29 months (maximum follow-up 21 months after completion of AdCTx \[Visit 10\]). For all participants who transfer to BNT122-01 (NCT04486378), study participation in BNT000-001 will end at time of screening for BNT122-01.
Study Type
OBSERVATIONAL
Enrollment
2,200
Blood samples for in vitro testing of ctDNA status will be drawn at study visits every 3 months for 21 months
Ridley-Tree Cancer Center
California City, California, United States
John Muir Clinical Research Center
Concord, California, United States
Marin Cancer Care
Greenbrae, California, United States
The Oncology Institute of Hope
Los Angeles, California, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States
Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample
Blood sample taken post-surgery and pre-adjuvant chemotherapy.
Time frame: 4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx
Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial
The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.
Time frame: 4 weeks following Visit 1 (upon availability of ctDNA positivity status)
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