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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059963
• Other study ID #: CRC-US-003
• Status: Recruiting
• Start date: January 18, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: January 2024
• Source: Universal Diagnostics
• Contact: Christian Hense
• Phone: (+1) 646 492 4041
• Email: christian[@]universaldx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: March 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Adenocarcinoma
• Colorectal Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Blue Ridge Medical Research	Lynchburg	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Universal Diagnostics	Premier Research Group plc, Science 37, Yanuvia, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year
Secondary	Secondary Objective	To determine sensitivity for advanced precancerous lesions (APL).	1 year