RECRUITING

Collection of Samples USOPTIVAL Study

Conditions

Colorectal Cancer (CRC)Advanced Adenomas (AA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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")

Quick Facts

Study Start:2020-12-30

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04792684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 84 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	1. Subject with curative biopsy during colonoscopy. 1. Subjects with positive FIT Test results in the 6 months preceding enrollment. 2. Subject has a current diagnosis of cancer. 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.

Inclusion Criteria

Exclusion 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.
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.

1. Subject with curative biopsy during colonoscopy.
1. Subjects with positive FIT Test results in the 6 months preceding enrollment.
2. Subject has a current diagnosis of cancer.
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.

Contacts and Locations

Study Contact

Erika Vento-Gaudens

CONTACT

(+1) 816-299-3060

erika.vento@universaldx.com

Study Locations (Sites)

Precision Recearch Institute

Chula Vista, California, 91910

United States

Precision Research Institute

San Diego, California, 92114

United States

Medical Associates Research Group

San Diego, California, 92123

United States

Clinical Research of California

Walnut Creek, California, 94598

United States

Center for Gastrointestinal Disorders

Hollywood, Florida, 33021

United States

Lakeland Regional Cancer Center

Lakeland, Florida, 33805

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Ochsner Clinic

New Orleans, Louisiana, 70121

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Mid Hudson Medical Research

New Windsor, New York, 12553

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Frontier Clinical Research

Uniontown, Pennsylvania, 15401

United States

Clinical Trials Network

Union City, Tennessee, 38261

United States

Vilo Research Group

Houston, Texas, 77017

United States

Gastroenterology Consultants of SW Virginia

Roanoke, Virginia, 24014

United States

Collaborators and Investigators

Sponsor: Universal Diagnostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-30

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2020-12-30

Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer (CRC)
Advanced Adenomas (AA)