DISCLAIMER: This site is for informational purposes only. While we make every effort to keep it up to date, there is no guarantee that information is complete, accurate, comprehensive, or the same for all KP regions. The information on this site should not be interpreted or used as a substitute for professional medical care. Please consult your care provider for any personal health questions or before participating in clinical trials.

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

Sex

Male & Female

Age Limit

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.

Keywords and/or Specific Medical Conditions

  • Gastroenterology
  • Oncology (Adult)

Sponsors

  • Universal Diagnostics

Clinical Area

  • Gastroenterology
  • Oncology (Adult)

Principal Investigator

Theodore Levin  

Contact Information

 - CTP Collaborate Team
- ctpcollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

Find a study