Trials / Recruiting
RecruitingNCT04792684
Collection of Samples USOPTIVAL Study
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance ("USOPTIVAL")
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,300 (estimated)
- Sponsor
- Universal Diagnostics · Industry
- Sex
- All
- Age
- 45 Years – 84 Years
- Healthy volunteers
- Accepted
Summary
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.
Detailed description
This study is designed to prospectively collect blood samples and clinical data from subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC scheduled for resection surgery, as well as subjects who are at average-risk of colorectal cancer and who are scheduled for routine colonoscopy examination. Subjects interested in participation and who meet inclusion criteria and provide written informed consent will be enrolled in the study. By accepting participation in the study, subjects will consent to provide up to 40 ml of blood at the study visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel | Evaluate the performance of a preliminary panel of biomarkers |
Timeline
- Start date
- 2020-12-30
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2021-03-11
- Last updated
- 2025-11-10
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04792684. Inclusion in this directory is not an endorsement.