Collection of Samples USOPTIVAL Study

Colorectal Cancer (CRC) Clinical Trial

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")

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792684
• Other study ID #: CRC-US-001
• Status: Recruiting
• Start date: December 30, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Universal Diagnostics
• Contact: Alvaro Leiva
• Phone: (+34) 674 94 55 33
• Email: aleiva[@]universaldx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Advanced Adenomas (AA)
• Colorectal Cancer (CRC)
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Precision Recearch Institute	Chula Vista	California
United States	Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Vilo Research Group	Houston	Texas
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Mid Hudson Medical Research	New Windsor	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Gastroenterology Consultants of SW Virginia	Roanoke	Virginia
United States	Medical Associates Research Group	San Diego	California
United States	Precision Research Institute	San Diego	California
United States	Springfield Clinic	Springfield	Illinois
United States	Clinical Trials Network	Union City	Tennessee
United States	Frontier Clinical Research	Uniontown	Pennsylvania
United States	Clinical Research of California	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Universal Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing	Samples Collected for Testing	Within 12 months of sample collection