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NCT04813627 · ClinicalTrials.gov registry record
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
A clinical trial of Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by BioNTech SE.
- Active
- Registry status
- 2,200
- Enrollment target
- 20
- Study locations
NCT04813627: Active study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by BioNTech SE.
NCT04813627 is a study of Colorectal Cancer Stage II and Colorectal Cancer Stage III that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 2,200 participants, above the 731-participant average among 6 other Colorectal Cancer Stage II trials with a reported enrollment target (201% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04813627, a study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- 2,200 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Blood sample taken post-surgery and pre-adjuvant chemotherapy.
Conditions Studied
Interventions
- PROCEDURE Regular blood sample collection for ctDNA assessment
Study Locations (20)
California
- Ridley-Tree Cancer Center - California City
- John Muir Clinical Research Center - Concord
- Marin Cancer Care - Greenbrae
- The Oncology Institute of Hope - Los Angeles
Texas
- Texas Oncology - Austin - Austin
- Texas Oncology - Baylor Charles A. Sammons Cancer Center - Dallas
- Texas Oncology - San Antonio Medical Center - San Antonio
- Texas Oncology - Northeast Texas - Tyler
Other
- ZNA Campus Middelheim - Antwerp
- Imelda Ziekenhuis - Bonheiden
- VZW Algemeen Ziekenhuis KLINA - Brasschaat
Illinois
- Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur - Decatur
- Orchard Healthcare Research Inc. - Skokie
Washington
- Rockwood Cancer Treatment Center - Spokane
- Northwest Cancer Specialists - Vancouver
Colorado
- Rocky Mountain Cancer Centers - Denver Midtown - Denver
New York
- USOR - New York Oncology Hematology, P.C. - Albany
Ohio
- Oncology Hematology Care Clinical Trials, LLC - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,200 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2026-04 |
What the registry record for NCT04813627 still lists
NCT04813627 is an observational study that tracks outcomes without assigning an intervention. Its 2,200 participants enrollment target places it among the larger protocols in the corpus, above the 731-participant average among 6 other Colorectal Cancer Stage II trials with a reported enrollment target (201% higher).
The record links to 2 conditions, with Colorectal Cancer Stage II appearing as the primary indexed condition, and to 1 intervention - of which Regular blood sample collection for ctDNA assessment is the first listed.
NCT04813627 names 20 study sites across 10 states, led by California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT04813627 about?
NCT04813627 is a clinical study titled "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". 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 mont...
What is the current status of trial NCT04813627?
This trial is currently active not recruiting. The enrollment target is 2,200 participants. The study started on 2021-07-02. Estimated completion is 2026-04.
What conditions does trial NCT04813627 study?
This clinical trial studies the following conditions: Colorectal Cancer Stage II, Colorectal Cancer Stage III.
What interventions are being tested in trial NCT04813627?
The interventions under investigation include: Regular blood sample collection for ctDNA assessment (PROCEDURE).
Who is sponsoring clinical trial NCT04813627?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04813627 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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