Clinical trial NCT04792684: 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")
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer (CRC)
Advanced Adenomas (AA)
Lead sponsor: Universal Diagnostics
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 1300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
timeFrame: Within 12 months of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Precision Recearch Institute
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California
state: California
city: Hollywood
country: United States
facility: Center for Gastrointestinal Disorders
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Uniontown
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Union City
country: United States
facility: Clinical Trials Network
state: Tennessee
city: Houston
country: United States
facility: Vilo Research Group
state: Texas
city: Roanoke
country: United States
facility: Gastroenterology Consultants of SW Virginia
state: Virginia
Study officials:
References: