CRC Detection Reliable Assessment With Blood

Overview

The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

Full Title of Study: “Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2024

Detailed Description

The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.

Interventions

  • Diagnostic Test: Next-Gen CRC Screening Test
    • The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.

Arms, Groups and Cohorts

  • Next-Gen CRC Screening Test
    • Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity for CRC of the Next-Gen CRC Screening Test
    • Time Frame: blood collection up to 90 days from colonoscopy
    • Clinical Performance
  • Specificity for CRC of the Next-Gen CRC Screening Test
    • Time Frame: blood collection up to 90 days from colonoscopy
    • Clinical Performance

Secondary Measures

  • Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
    • Time Frame: blood collection up to 90 days from colonoscopy
    • Clinical Performance
  • Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
    • Time Frame: blood collection up to 90 days from colonoscopy
    • Clinical Performance

Participating in This Clinical Trial

Inclusion Criteria

1. Participant is 45 years of age or older at time of enrollment. 2. Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria) 3. Participant is able and willing to undergo a screening colonoscopy 4. Participant is able and willing to sign informed consent and adhere to study requirements 5. Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy). Exclusion Criteria:

1. Previous personal history of CRC or precancerous lesions 2. Positive result from non-invasive screening test within the associated recommended intervals: 2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months 3. Diagnosed with condition associated with higher risk for colorectal cancer, such as: 3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC 4. Individuals with relevant familial (hereditary) cancer syndrome, such as: 4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis 5. Diagnosed with chronic gastritis or cirrhosis 6. Current diagnosis of any cancer, except non-melanoma skin cancer 7. Overt rectal bleeding or bleeding hemorrhoids within previous 30 days 8. A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation 9. Pregnancy

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Epigenomics, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Alejandra Maciel, 8585251789, alejandra.maciel@epigenomics.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.