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

Sponsor
Universal Diagnostics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059963
Collaborator
Premier Research Group plc (Industry), Yanuvia, LLC (Other), Science 37 (Industry)
15,000
Enrollment
29
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Signal-C™

Study Design

Study Type:
Observational
Anticipated Enrollment :
15000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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™
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).

Outcome Measures

Primary Outcome Measures

  1. Primary Objective [1 year]

    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).

Secondary Outcome Measures

  1. Secondary Objective [1 year]

    To determine sensitivity for advanced precancerous lesions (APL).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

  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 clinical evidence and documentation of being cancer free and patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study.)

  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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universal Diagnostics
  • Premier Research Group plc
  • Yanuvia, LLC
  • Science 37

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universal Diagnostics
ClinicalTrials.gov Identifier:
NCT06059963
Other Study ID Numbers:
  • CRC-US-003
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Universal Diagnostics
Advanced Precancerous Lesions
Additional relevant MeSH terms:
Adenocarcinoma

Study Results

No Results Posted as of Sep 29, 2023