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

Part of paid clinical trials in Raonoke, Virginia.

Sponsor
Universal Diagnostics
Study ID
NCT06059963
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 84 Years
Healthy Volunteers
Accepted

Interventions

  • Signal-C™ — DEVICE
    Signal-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).

Study Details

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.

Key Dates

Start date
Jan 18, 2024
Status verified
Nov 2025
Primary completion
Oct 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
12,000 participants (estimated)

Arms

  • Arm: Average risk
    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.

Primary Outcome Measure

Primary Objective [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gastroenterology Consultants of SW VirginiaRaonokeVirginia24014
Vishal Bhagat

Find similar trials in Raonoke, VA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Gastroenterology Consultants of SW Virginia· Raonoke, VA

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