RecruitingNCT06059963

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

Sponsor

Universal Diagnostics

Enrollment

12,000 participants

Start Date

Jan 18, 2024

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer Advanced Adenocarcinoma

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

Min Age: 45 YearsMax Age: 84 Years

Inclusion Criteria6

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

Exclusion Criteria14

Undergoing colonoscopy for investigation of CRC risk symptoms
Has undergone colonoscopy within preceding 9 years
Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
Has completed Cologuard or Epi proColon testing within the previous 3 years.
Has undergone a CT colonography in the prior 4 years.
History of colorectal cancer.
History of any malignancy within prior 5 years.
Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
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.
Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
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.
Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
Known pregnancy at informed consent, blood sample collection, and during study participation.
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.

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).