Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance
Part of paid clinical trials in Lake Barrington, Illinois.
- Sponsor
- Universal Diagnostics
- Study ID
- NCT07310446
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 84 Years
- Healthy Volunteers
- Accepted
Study Details
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
Key Dates
- Start date
- Jul 31, 2023
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 6,500 participants (estimated)
Arms
- Arm: Arm APatients newly diagnosed with CRC who have not yet had treatment or surgery.
- Arm: Arm BPeople at average risk of CRC undergoing screening for colorectal cancer with colonoscopy.
Primary Outcome Measure
Development of assay [ Time Frame: Baseline ]
Central Contacts
- Antonio Jesus Merino Calvo674945571
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gastroenterology and Internal Medicine Specialists | Lake Barrington | Illinois | 60010 | Manish Bhuva, MD (PRINCIPAL_INVESTIGATOR) |
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