Recruiting NCT06059963
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Signal-C™.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Advanced Adenocarcinoma. Basic parameters: 45 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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).
Primary outcome measures
- Primary Objective [Time frame: 1 year]
Secondary outcome measures (1)
- Secondary Objective [Time frame: 1 year]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Gastroenterology Consultants of SW Virginia — Raonoke
Identifiers
NCT: NCT06059963 · CRC-US-003