Collection of Samples USOPTIVAL Study

Recruiting

• Conditions: Colorectal Cancer (CRC); Advanced Adenomas (AA)
• Interventions: Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

• Registration Number: NCT04792684
• Lead Sponsor: Universal Diagnostics

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 selected by the Sponsor for CRC and advanced adenoma detection.

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 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.

Study Timeline

• Study Start: 2020-12-30
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B	Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel	Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy
Arm A.	Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel	Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery

Primary Outcome Measures

Name	Time	Method
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing	Within 12 months of sample collection	Samples Collected for Testing

Trial Locations

Locations (16)

Springfield Clinic; 🇺🇸 Springfield, Illinois, United States

Ochsner Clinic; 🇺🇸 New Orleans, Louisiana, United States

Precision Research Institute; 🇺🇸 San Diego, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

Center for Gastrointestinal Disorders; 🇺🇸 Hollywood, Florida, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Vilo Research Group; 🇺🇸 Houston, Texas, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Precision Recearch Institute; 🇺🇸 Chula Vista, California, United States

Clinical Research of California; 🇺🇸 Walnut Creek, California, United States

Lakeland Regional Cancer Center; 🇺🇸 Lakeland, Florida, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Gastroenterology Consultants of SW Virginia; 🇺🇸 Roanoke, Virginia, United States

Frontier Clinical Research; 🇺🇸 Uniontown, Pennsylvania, United States

Clinical Trials Network; 🇺🇸 Union City, Tennessee, United States

Mid Hudson Medical Research; 🇺🇸 New Windsor, New York, United States