CRC Detection Reliable Assessment With Blood

Colorectal Cancer Clinical Trial

— CRC-DRAW  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05551052
• Other study ID #: SPR0033P
• Status: Active, not recruiting
• Start date: September 8, 2022
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Epigenomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer
• Colon Disease
• Colon Lesion
• Colon Neoplasm
• Colon Polyp
• Colonic Diseases
• Colonic Diseases, Functional
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Intestinal Disease
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasms
• Polyps
• Rectal Cancer
• Rectal Diseases
• Rectal Polyp

Intervention

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

Locations

Country	Name	City	State
United States	Gastro SB	Chula Vista	California
United States	Medical Associates Research Group	San Diego	California
United States	SDG Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for CRC of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy
Primary	Specificity for CRC of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy
Secondary	Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy
Secondary	Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy