Active, currently enrolling
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
NCT No.: NCT06059963
Study Type: OBSERVATIONAL
Phase:
Region: California - Northern
Acronym:
Official Title
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Purpose
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.
Detailed Description
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
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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.
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Keywords and/or Specific Medical Conditions
Sponsors
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