CRC Detection Reliable Assessment With Blood

Active, not recruiting

• Conditions: Adenomas Colon; Rectal Diseases; Colon Cancer; Rectal Polyp; Colon Neoplasm; Colon Polyp; Gastrointestinal Neoplasms; Colonic Diseases, Functional; Intestinal Disease; Colorectal Cancer
• Interventions: Diagnostic Test: Next-Gen CRC Screening Test

• Registration Number: NCT05551052
• Lead Sponsor: Epigenomics, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-09-08
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23
• Primary Completion: 2024-03
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Next-Gen CRC Screening Test	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

SDG Clinical Research; 🇺🇸 San Diego, California, United States

Gastro SB; 🇺🇸 Chula Vista, California, United States