Colorectal Cancer Clinical Trial
— CRC-DRAWOfficial title:
Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
Verified date | May 2023 |
Source | Epigenomics, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
Status | Active, not recruiting |
Enrollment | 196 |
Est. completion date | July 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Epigenomics, Inc |
United States,
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 |
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