Collection of Samples USOPTIVAL Study

• ClinicalTrials.gov Identifier: NCT04792684
• Recruitment Status: Recruiting
• First Posted: March 11, 2021
• Last Update Posted: January 27, 2023
• Sponsor: Universal Diagnostics
• Information provided by (Responsible Party): Universal Diagnostics

Tracking Information

• First Submitted Date: March 8, 2021
• First Posted Date: March 11, 2021
• Last Update Posted Date: January 27, 2023
• Actual Study Start Date: December 30, 2020
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2021)

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

Samples Collected for Testing

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Collection of Samples USOPTIVAL Study
• 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")
• 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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

40 ml of blood at the study visit processed for plasma

• 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.

Condition

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

Intervention

Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

Evaluate the performance of a preliminary panel of biomarkers

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 26, 2023): 1300
• Original Estimated Enrollment (submitted: March 8, 2021): 1100
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 45 Years to 84 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04792684
• Other Study ID Numbers: CRC-US-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Universal Diagnostics
• Original Responsible Party: Same as current
• Current Study Sponsor: Universal Diagnostics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universal Diagnostics
• Verification Date: January 2023