CClinicalTrials.gg
RecruitingNCT06059963Updated Nov 10, 2025

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

An observational study in Colorectal Cancer and Advanced Adenocarcinoma, sponsored by Universal Diagnostics. Recruiting at 1 site in United States. Open to participants aged 45 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by Universal Diagnostics · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,000
Ages
45 Years to 84 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Advanced Adenocarcinoma

Keywords

  • Advanced Precancerous Lesions
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Universal Diagnostics is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Inclusion criteria

  1. Subjects aged 45-84 years at time of consent
  2. Intended to undergo a standard-of-care screening colonoscopy
  3. Considered by a physician or healthcare provider as being of 'average risk' for CRC
  4. 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.
  5. Willing to consent to follow-up for one year as per protocol
  6. Able and willing to sign informed consent

Exclusion criteria

Exclusion Criteria:

  1. Undergoing colonoscopy for investigation of CRC risk symptoms
  2. Has undergone colonoscopy within preceding 9 years
  3. Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
  4. Has completed Cologuard or Epi proColon testing within the previous 3 years.
  5. Has undergone a CT colonography in the prior 4 years.
  6. History of colorectal cancer.
  7. History of any malignancy within prior 5 years.
  8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
  9. Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age \<60 years or with more than one first-degree relative diagnosed with CRC at any age.
  10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]).
  11. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  13. Known pregnancy at informed consent, blood sample collection, and during study participation.
  14. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Device: Signal-C™

Interventions

  • DeviceSignal-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).

06

What researchers measure

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 year

Secondary outcomes

  1. Secondary Objective

    To determine sensitivity for advanced precancerous lesions (APL). To determine NPV and PPV for colorectal cancer.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Gastroenterology Consultants of SW Virginia
    Raonoke, Virginia 24014, United States
    • Vishal Bhagat · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06059963
Lead sponsor
Universal Diagnostics
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Jan 18, 2024
Primary completion
Oct 30, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 10, 2025

Study contacts

Kara Mattox
Contact
kara.mattox@universaldx.com
(+1)3392085320

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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