CRC Detection Reliable Assessment With Blood (CRC-DRAW)

Epigenomics

Status: Active, not recruiting

Conditions: Colon Lesion; Colon Neoplasm; Colon Disease; Colon Cancer; Adenomas Colon; Rectal Polyp; Gastrointestinal Neoplasms; Adenoma; Colonic Diseases, Functional; Intestinal Disease; Intestinal Neoplasms; Polyps; Rectal Diseases; Colon Polyp; Rectal Cancer; Colorectal Cancer

Treatments: Diagnostic Test: Next-Gen CRC Screening Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05551052

SPR0033P

Details and patient eligibility

About

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 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.

Enrollment: 196 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

196 participants in 1 patient group

Next-Gen CRC Screening Test

Description:

Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

Treatment:

Diagnostic Test: Next-Gen CRC Screening Test