An observational study in Colorectal Cancer, Adenomas Colon and Colon Cancer, sponsored by New Day Diagnostics. Active, not recruiting at 3 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by New Day Diagnostics · 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.
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 196 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →New Day Diagnostics is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
Diagnostic Test: Next-Gen CRC Screening Test
The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.
Sensitivity for CRC of the Next-Gen CRC Screening Test
Clinical Performance
Time frame: blood collection up to 90 days from colonoscopy
Specificity for CRC of the Next-Gen CRC Screening Test
Clinical Performance
Time frame: blood collection up to 90 days from colonoscopy
Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
Clinical Performance
Time frame: blood collection up to 90 days from colonoscopy
Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
Clinical Performance
Time frame: blood collection up to 90 days from colonoscopy
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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New Day Diagnostics