CRC Detection Reliable Assessment With Blood

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

45 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not reported

Participants

196 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Study team and timeline

Lead sponsor

New Day Diagnostics

Study start

Sep 8, 2022 Actual

Primary completion

Oct 31, 2028 Estimated

Study completion

Dec 31, 2029 Estimated

First posted

Sep 22, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.