CRC Detection Reliable Assessment With Blood

Running, not enrolling

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT05551052

Run by

New Day Diagnostics

People needed

196

Starts

2022-09-08

Expected to finish

2027-12-31

Last updated by the study team

2025-05-29

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Previous personal history of CRC or precancerous lesions
• Positive result from non-invasive screening test within the associated recommended intervals:
• 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:
• 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:
• 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

Where it is running

• Gastro SB — Chula Vista, California, United States
• SDG Clinical Research — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States

Full record on ClinicalTrials.gov

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