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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

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NCT04813627

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.

Phase
Status
Completed
Study type
Observational
Enrollment
2,079actual
Sites
74
Countries
Belgium, Germany, Spain +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-07-02actualWhen the study began enrolling
Primary completion2025-04-23actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-04-23actualThe whole study's end, after follow-up
First posted2021-03-24actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-22actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Intervention

  • Procedure: Regular blood sample collection for ctDNA assessment

Primary outcome

what the primary-completion date above is the date OF
Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample
measured 4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx

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