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ACTIVE NOT RECRUITING

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 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 2,200 participants
Start Date 2021-07-02
Est. Completion 2026-04

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04813627

The ClinicalTrials.gov registry entry for NCT04813627 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04813627 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04813627?

The interventions under investigation include: Regular blood sample collection for ctDNA assessment (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04813627?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial