Colon Cancer Clinical Trial

CRC Detection Reliable Assessment With Blood

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.

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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.

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Eligibility Criteria

Inclusion Criteria:

Participant is 45 years of age or older at time of enrollment.
Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria)
Participant is able and willing to undergo a screening colonoscopy
Participant is able and willing to sign informed consent and adhere to study requirements
Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy).

Exclusion Criteria:

Previous personal history of CRC or precancerous lesions

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

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

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

Diagnosed with chronic gastritis or cirrhosis
Current diagnosis of any cancer, except non-melanoma skin cancer
Overt rectal bleeding or bleeding hemorrhoids within previous 30 days
A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation
Pregnancy

Study is for people with:

Colon Cancer

Estimated Enrollment:

196

Study ID:

NCT05551052

Recruitment Status:

Active, not recruiting

Sponsor:

Epigenomics, Inc

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There are 3 Locations for this study

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Gastro SB
Chula Vista California, 91910, United States
SDG Clinical Research
San Diego California, 92103, United States
Medical Associates Research Group
San Diego California, 92123, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

196

Study ID:

NCT05551052

Recruitment Status:

Active, not recruiting

Sponsor:


Epigenomics, Inc

How clear is this clinincal trial information?

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