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")
Universal Diagnostics
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.
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.
Eligibility
- Age range
- 45–84 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Arm A: 1. Must be 45-84 years of age. 2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery. 3. Able to comprehend, sign, and date the written informed consent document. Arm B: 1. Must be 45-84 years of age. 2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days. 3. Able to comprehend, sign, and date the written informed consent document. Exclusion Criteria: Arm A Only: 1\. Subject with curative biopsy during colonoscopy. Arm B Only: 1. Subjects with positive FIT Test…
Interventions
- Diagnostic TestOptimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers
Locations (16)
- Precision Recearch InstituteChula Vista, California
- Precision Research InstituteSan Diego, California
- Medical Associates Research GroupSan Diego, California
- Clinical Research of CaliforniaWalnut Creek, California
- Center for Gastrointestinal DisordersHollywood, Florida
- Lakeland Regional Cancer CenterLakeland, Florida