US company collects a Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance
The company Universal Diagnostics is conducting the clinical trial Collection of Samples USOPTIVAL Study.
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.
It is planned to include 1100 participants.
Actual study start date is December 30, 2020. The researchers expect to complete the study by December 31, 2021.
One primary outcome measure is Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing, Samples Collected for Testing.
Among study population are 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.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04792684) San Diego, Walnut Creek, Hollywood, Lakeland, Springfield, New Orleans, New Windsor, Philadelphia, Philadelphia, Uniontown, Union City, Houston and Roanoke, United States.
