Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1300 participants
OBSERVATIONAL
2020-12-30
2025-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Arm A.
Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers
Arm B
Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers
Interventions
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Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
84 Years
ALL
Yes
Sponsors
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Universal Diagnostics
INDUSTRY
Responsible Party
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Locations
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Precision Recearch Institute
Chula Vista, California, United States
Precision Research Institute
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Clinical Research of California
Walnut Creek, California, United States
Center for Gastrointestinal Disorders
Hollywood, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Springfield Clinic
Springfield, Illinois, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mid Hudson Medical Research
New Windsor, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Frontier Clinical Research
Uniontown, Pennsylvania, United States
Clinical Trials Network
Union City, Tennessee, United States
Vilo Research Group
Houston, Texas, United States
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Manuel Molina
Role: primary
Peter Hofmann
Role: primary
Sashi Makam
Role: primary
Bryson Katona
Role: primary
Other Identifiers
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CRC-US-001
Identifier Type: -
Identifier Source: org_study_id