Status:
RECRUITING
Collection of Samples USOPTIVAL Study
Lead Sponsor:
Universal Diagnostics
Conditions:
Colorectal Cancer (CRC)
Advanced Adenomas (AA)
Eligibility:
All Genders
45-84 years
Brief 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 sele...
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 surge...
Eligibility Criteria
Inclusion
- Arm A:
- Must be 45-84 years of age.
- Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
- Able to comprehend, sign, and date the written informed consent document.
- Arm B:
- Must be 45-84 years of age.
- Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.
- Able to comprehend, sign, and date the written informed consent document.
Exclusion
- Arm A Only:
- 1\. Subject with curative biopsy during colonoscopy.
- Arm B Only:
- Subjects with positive FIT Test results in the 6 months preceding enrollment.
- Subject has a current diagnosis of cancer.
- Arms A \& B:
- Subject has a personal history of aerodigestive or digestive tract cancers.
- Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
- Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Familial adenomatous polyposis ("FAP", including attenuated FAP).
- Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome").
- Serrated polyposis syndrome
- 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.
- One first-degree relative with CRC diagnosed before the age of 60.
- A significant disease which, in the Investigator's opinion, would exclude the subject from the study.
- Legal incapacity or limited mental capacity.
- Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.
- The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions.
- The patient is known to be pregnant when recruited or during her participation in the study.
Key Trial Info
Start Date :
December 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT04792684
Start Date
December 30 2020
End Date
December 30 2025
Last Update
November 7 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Precision Recearch Institute
Chula Vista, California, United States, 91910
2
Precision Research Institute
San Diego, California, United States, 92114
3
Medical Associates Research Group
San Diego, California, United States, 92123
4
Clinical Research of California
Walnut Creek, California, United States, 94598