A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
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
This trial accepts healthy volunteersQualifiers
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 population
Patients aged between 45 and 84, who are at average risk of developing colorectal cancer, and are scheduled for a standard-of-care screening colonoscopy. Approximately 12,000 subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final histopathological diagnosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Signal-C™
DeviceSignal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs).
Treatment groups
12,000 Participants
are divided into 1 treatment groupGroup A: Average risk1 intervention
Trial outcomes
Primary outcomes
1
Primary Objective
The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).
Time frame
1 yearSecondary outcomes
1
Secondary Objective
To determine sensitivity for advanced precancerous lesions (APL). To determine NPV and PPV for colorectal cancer.
Time frame
1 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Gastroenterology Consultants of SW VirginiaRecruiting24014, Raonoke, Virginia
United States
United StatesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov