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
Public ClinicalTrials.gov record NCT04813627. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Epidemiological Study to Determine the Prevalence of ctDNA Positivity in Participants With Stage II (High Risk) or Stage III CRC After Surgery With Curative (R0) Intent and Subsequent Adjuvant Chemotherapy With Monitoring of ctDNA During Clinical Follow-up
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04813627
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,079 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2021 (Actual)
- Primary completion
- Apr 23, 2025 (Actual)
- Completion
- Apr 23, 2026 (Actual)
- Last update posted
- May 22, 2026
2021 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ridley-Tree Cancer Center | California City | California | 93105 | — |
| John Muir Clinical Research Center | Concord | California | 94520 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| The Oncology Institute of Hope | Los Angeles | California | 90033 | — |
| Rocky Mountain Cancer Centers - Denver Midtown | Denver | Colorado | 80218 | — |
| Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur | Decatur | Illinois | 62526 | — |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | — |
| USOR - New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| Oncology Hematology Care Clinical Trials, LLC | Cincinnati | Ohio | 45245 | — |
| USOR - Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Texas Oncology - Austin | Austin | Texas | 78705 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78229 | — |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Rockwood Cancer Treatment Center | Spokane | Washington | 99204 | — |
| Northwest Cancer Specialists | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04813627, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04813627 live on ClinicalTrials.gov.