Clinical trial NCT06059963: A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Official title: A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Advanced Adenocarcinoma
Keywords: Advanced Precancerous Lesions
Lead sponsor: Universal Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
name: Yanuvia, LLC
name: Science 37
First posted: 2023-09-29
Enrollment: 15000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Approximately 15,000K subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final diagnosis.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Objective
timeFrame: 1 year
Secondary outcomes:
measure: Secondary Objective
timeFrame: 1 year
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
Study officials:
References: