Trials / Recruiting
RecruitingNCT06059963
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 12,000 (estimated)
- Sponsor
- Universal Diagnostics · Industry
- Sex
- All
- Age
- 45 Years – 84 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Signal-C™ | 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). |
Timeline
- Start date
- 2024-01-18
- Primary completion
- 2026-10-30
- Completion
- 2026-12-01
- First posted
- 2023-09-29
- Last updated
- 2025-11-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06059963. Inclusion in this directory is not an endorsement.