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

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer, Advanced Adenocarcinoma

Intervention / Treatment
-----------------
* Device: Signal-C™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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. (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.) 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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Average risk<br>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™<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective | To determine sensitivity for advanced precancerous lesions (APL). | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Precancerous Lesions