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NCT05551052Active, not recruiting

CRC Detection Reliable Assessment With Blood

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

Source: ClinicalTrials.gov · Last updated 29 May 2025

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Study type
Observational
Enrollment
196 (actual)
First submitted
20 Sept 2022
Start date
8 Sept 2022
Primary completion date
31 Oct 2027
Lead sponsor
New Day Diagnostics
NCT number
NCT05551052

What you commit to

  • Study type: Observational
  • Participants enrolled: 196
  • From 8 Sept 2022 to the primary completion date, 31 Oct 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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
  • Current diagnosis of any cancer, except non-melanoma skin cancer

Age

  • 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

Other

  • Diagnosed with chronic gastritis or cirrhosis
  • Pregnancy

Who the study is looking for

  • 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).

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gastro SB
Coordinator of this site? Confirm its status
Chula VistaUnited StatesUnknown status
Medical Associates Research Group
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
SDG Clinical Research
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.