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Collection of Samples USOPTIVAL Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04792684
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
Universal Diagnostics

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer (CRC) Advanced Adenomas (AA) 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 Design
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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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")
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing [ Time Frame: Within 12 months of sample collection ]
    Samples Collected for Testing


Biospecimen Retention:   Samples With DNA
40 ml of blood at the study visit processed for plasma

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792684


Contacts
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Contact: Alvaro Leiva (+34) 674 94 55 33 aleiva@universaldx.com

Locations
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United States, California
Precision Recearch Institute Completed
Chula Vista, California, United States, 91910
Precision Research Institute Completed
San Diego, California, United States, 92114
Medical Associates Research Group Completed
San Diego, California, United States, 92123
Clinical Research of California Completed
Walnut Creek, California, United States, 94598
United States, Florida
Center for Gastrointestinal Disorders Completed
Hollywood, Florida, United States, 33021
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Manuel Molina         
United States, Illinois
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Peter Hofmann         
United States, Louisiana
Ochsner Clinic Completed
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Dana Farber Cancer Institute Completed
Boston, Massachusetts, United States, 02215
United States, New York
Mid Hudson Medical Research Recruiting
New Windsor, New York, United States, 12553
Contact: Sashi Makam         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bryson Katona         
Fox Chase Cancer Center Completed
Philadelphia, Pennsylvania, United States, 19111
Frontier Clinical Research Completed
Uniontown, Pennsylvania, United States, 15401
United States, Tennessee
Clinical Trials Network Completed
Union City, Tennessee, United States, 38261
United States, Texas
Vilo Research Group Completed
Houston, Texas, United States, 77017
United States, Virginia
Gastroenterology Consultants of SW Virginia Recruiting
Roanoke, Virginia, United States, 24014
Contact: Vishal Bhagat         
Sponsors and Collaborators
Universal Diagnostics
More Information
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Responsible Party: Universal Diagnostics
ClinicalTrials.gov Identifier: NCT04792684    
Other Study ID Numbers: CRC-US-001
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type