Collection of Samples USOPTIVAL Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-84
SponsorUniversal Diagnostics
About this trial
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.
Eligibility criteria
Qualifiers
Must be 45-84 years of age.
Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
Able to comprehend, sign, and date the written informed consent document.
Must be 45-84 years of age.
Disqualifiers
Subjects with positive FIT Test results in the 6 months preceding enrollment.
Subject has a current diagnosis of cancer.
Subject has a personal history of aerodigestive or digestive tract cancers.
Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
Trial design
Treatments tested in this trial
- Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Treatment groups
1,300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov