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

Last updated: August 30, 2024
Sponsor: Universal Diagnostics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Rectal Cancer

Cancer

Treatment

Signal-C™

Clinical Study ID

NCT06059963
CRC-US-003
  • Ages 45-84
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 undergoingcolonoscopy 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

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. (Patients with clear clinicalevidence and documentation of being cancer free and patients who have undergonesurgical removal of skin squamous cell cancer may be enrolled provided the procedurewas completed at least 12 months prior to the date of provision of informed consentfor the study.)

  8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerativecolitis (CUC) and Crohn's disease (CD).

  9. Positive family history of colorectal cancer, defined as having a first- degreerelative (parent, sibling, or child) with CRC diagnosed at age <60 years or withmore than one first-degree relative diagnosed with CRC at any age.

  10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome orHereditary 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 ofinformed consent.

  12. Known medical condition which, in the opinion of the investigator, should precludeenrollment into the study.

  13. Known pregnancy at informed consent, blood sample collection, and during studyparticipation.

  14. Participation in a clinical research study in which an experimental medication hasbeen administered or may be administered within the 30 days leading up to providinginformed consent or may be administered through the time of colonoscopy.

Study Design

Total Participants: 15000
Treatment Group(s): 1
Primary Treatment: Signal-C™
Phase:
Study Start date:
January 18, 2024
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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