Collection of Samples USOPTIVAL Study

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")

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer (CRC); Advanced Adenomas (AA)
• Intervention / Treatment: Diagnostic test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

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 Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Alvaro Leiva; Phone Number: (+34) 674 94 55 33; Email: aleiva@universaldx.com

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Completed
      • Precision Recearch Institute
    • San Diego, California, United States, 92114
      • Completed
      • Precision Research Institute
    • San Diego, California, United States, 92123
      • Completed
      • Medical Associates Research Group
    • Walnut Creek, California, United States, 94598
      • Completed
      • Clinical Research of California
  • Florida
    • Hollywood, Florida, United States, 33021
      • Completed
      • Center for Gastrointestinal Disorders
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Lakeland Regional Cancer Center
      • Contact: Manuel Molina
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Springfield Clinic
      • Contact: Peter Hofmann
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Completed
      • Ochsner Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Completed
      • Dana Farber Cancer Institute
  • New York
    • New Windsor, New York, United States, 12553
      • Recruiting
      • Mid Hudson Medical Research
      • Contact: Sashi Makam
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Bryson Katona
    • Philadelphia, Pennsylvania, United States, 19111
      • Completed
      • Fox Chase Cancer Center
    • Uniontown, Pennsylvania, United States, 15401
      • Completed
      • Frontier Clinical Research
  • Tennessee
    • Union City, Tennessee, United States, 38261
      • Completed
      • Clinical Trials Network
  • Texas
    • Houston, Texas, United States, 77017
      • Completed
      • Vilo Research Group
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Completed
      • Gastroenterology Consultants of SW Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or have been newly diagnosed with CRC, still not resected and scheduled for surgery, and patients who are at average risk of developing colorectal cancer, scheduled for a standard-of-care screening colonoscopy.

Subjects will be considered enrolled after understanding and signing the ICF and a determination is made by the Investigator that the subject is eligible to participate according to the inclusion/exclusion criteria.

Enrollment will be stopped when a sufficient number of confirmed cases of colorectal cancer, advanced adenomas, and matching control subjects have been enrolled. Under the current assumptions, 1,200 subjects will need to be enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A.; Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery	Diagnostic test: 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	Diagnostic test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel; Evaluate the performance of a preliminary panel of biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing	Samples Collected for Testing	Within 12 months of sample collection

Collaborators and Investigators

• Sponsor: Universal Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: CRC-US-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No