Collection of Samples USOPTIVAL Study

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.

Conditions

Colorectal Cancer (CRC), Advanced Adenomas (AA)

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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")

Collection of Samples USOPTIVAL Study

Condition
Colorectal Cancer (CRC)
Intervention / Treatment

-

Contacts and Locations

Chula Vista

Precision Recearch Institute, Chula Vista, California, United States, 91910

San Diego

Precision Research Institute, San Diego, California, United States, 92114

San Diego

Medical Associates Research Group, San Diego, California, United States, 92123

Walnut Creek

Clinical Research of California, Walnut Creek, California, United States, 94598

Hollywood

Center for Gastrointestinal Disorders, Hollywood, Florida, United States, 33021

Lakeland

Lakeland Regional Cancer Center, Lakeland, Florida, United States, 33805

Springfield

Springfield Clinic, Springfield, Illinois, United States, 62702

New Orleans

Ochsner Clinic, New Orleans, Louisiana, United States, 70121

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New Windsor

Mid Hudson Medical Research, New Windsor, New York, United States, 12553

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

45 Years to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Universal Diagnostics,

Study Record Dates

2024-12-30