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Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

NCT04813627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2079

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Interventions

PROCEDURE

Regular blood sample collection for ctDNA assessment

Blood samples for in vitro testing of ctDNA status will be drawn at study visits every 3 months for 21 months

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2025-04-23
Completion
2026-04-23

Countries

  • United States
  • Belgium
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04813627 on ClinicalTrials.gov