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Collection of Samples USOPTIVAL Study
NCT04792684 · Universal Diagnostics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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")
About this study
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 criteria
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 results in the 6 months preceding enrollment.
2. Subject has a current diagnosis of cancer.
Arms A \& B:
1. Subject has a personal history of aerodigestive or digestive tract cancers.
2. Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
3. Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:
1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
2. Familial adenomatous polyposis ("FAP", including attenuated FAP).
3. Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome").
4. Serrated polyposis syndrome
5. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.
6. One first-degree relative with CRC diagnosed before the age of 60.
4. A significant disease which, in the Investigator's opinion, would exclude the subject from the study.
5. Legal incapacity or limited mental capacity.
6. Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.
7. 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.
8. The patient is known to be pregnant when recruited or during her participation in the study.
Study design
Enrollment target: 1300 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-12-30
Estimated completion: 2025-12-30
Last updated: 2025-11-10
Interventions
Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Primary outcomes
- • Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing (Within 12 months of sample collection)
Sponsor
Universal Diagnostics · industry
Contacts & investigators
ContactAntonio Jesus Merino Calvo · contact · antonio.merino@universaldx.com · (+34)674945571
All locations (16)
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Chula Vista, California, United States
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Center for Gastrointestinal DisordersCompleted
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Lakeland Regional Cancer CenterRecruiting
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Springfield ClinicRecruiting
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Ochsner ClinicCompleted
New Orleans, Louisiana, United States
Dana Farber Cancer InstituteCompleted
Boston, Massachusetts, United States
Mid Hudson Medical ResearchRecruiting
New Windsor, New York, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterCompleted
Philadelphia, Pennsylvania, United States
Frontier Clinical ResearchCompleted
Uniontown, Pennsylvania, United States
Clinical Trials NetworkCompleted
Union City, Tennessee, United States
Vilo Research GroupCompleted
Houston, Texas, United States
Gastroenterology Consultants of SW VirginiaCompleted
Raonoke, Virginia, United States