Health Trials

A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

ConditionsColorectal CancerAdvanced Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-84
SponsorUniversal Diagnostics

About this trial

To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.

Eligibility criteria

Qualifiers

Subjects aged 45-84 years at time of consent

Intended to undergo a standard-of-care screening colonoscopy

Considered by a physician or healthcare provider as being of 'average risk' for CRC

Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.

Disqualifiers

Undergoing colonoscopy for investigation of CRC risk symptoms

Has undergone colonoscopy within preceding 9 years

Positive FIT/FOBT result within the previous 12 months (+/- 3 months)

Has completed Cologuard or Epi proColon testing within the previous 3 years.

Trial design

Treatments tested in this trial

  • Signal-C™

Treatment groups

12,000 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Gastroenterology Consultants of SW VirginiaRecruiting24014, Raonoke, VirginiaUnited StatesUnited States

Sponsors and collaborators

Universal Diagnostics

Lead sponsor

Source ClinicalTrials.gov