CRC-DRAW: CRC Detection Reliable Assessment With Blood

• Sponsor: Epigenomics, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05551052
• Collaborator: (none)
• Enrollment: 20,000
• Locations: 3
• Anticipated Duration (Months): 21.7
• Patients Per Site: 6666.7
• Patients Per Site Per Month: 306.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Adenomas Colon; Colon Cancer; Rectal Cancer; Colon Neoplasm; Colon Lesion; Colon Disease; Colon Polyp; Polyps; Adenoma; Rectal Diseases; Rectal Polyp; Gastrointestinal Neoplasms; Intestinal Neoplasms; Colonic Diseases, Functional; Intestinal Disease	Diagnostic Test: Next-Gen CRC Screening Test

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 Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
• Actual Study Start Date: Sep 8, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: Next-Gen CRC Screening Test; The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.

Outcome Measures

Primary Outcome Measures

1. Sensitivity for CRC of the Next-Gen CRC Screening Test [blood collection up to 90 days from colonoscopy]

   Clinical Performance

2. Specificity for CRC of the Next-Gen CRC Screening Test [blood collection up to 90 days from colonoscopy]

   Clinical Performance

Secondary Outcome Measures

1. Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test [blood collection up to 90 days from colonoscopy]

   Clinical Performance

2. Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test [blood collection up to 90 days from colonoscopy]

   Clinical Performance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All

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

1. 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

1. 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

1. Diagnosed with chronic gastritis or cirrhosis

2. Current diagnosis of any cancer, except non-melanoma skin cancer

3. Overt rectal bleeding or bleeding hemorrhoids within previous 30 days

4. A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation

5. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastro SB	Chula Vista	California	United States	91910
2	SDG Clinical Research	San Diego	California	United States	92103
3	Medical Associates Research Group	San Diego	California	United States	92123

Sponsors and Collaborators

• Epigenomics, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Epigenomics, Inc
• ClinicalTrials.gov Identifier: NCT05551052
• Other Study ID Numbers: SPR0033P
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Adenoma; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases, Functional; Polyps

Study Results

No Results Posted as of Sep 22, 2022