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Active, Not Recruiting

NCT Number: NCT05551052

CRC Detection Reliable Assessment With Blood

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Cancer Adenoma Adenomas Colon Colon Cancer Colon Disease Colon Lesion Colon Neoplasm Colon Polyp Colonic Diseases Colonic Diseases, Functional Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Disease Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Cancer Rectal Diseases Rectal Neoplasms Rectal Polyp

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastro SB, Chula Vista, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Next-Gen CRC Screening Test

Diagnostic Test

The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.

Primary outcomes

  1. Sensitivity for CRC of the Next-Gen CRC Screening Test

    Time frame: blood collection up to 90 days from colonoscopy

    Clinical Performance

  2. Specificity for CRC of the Next-Gen CRC Screening Test

    Time frame: blood collection up to 90 days from colonoscopy

    Clinical Performance

Secondary outcomes

  1. Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test

    Time frame: blood collection up to 90 days from colonoscopy

    Clinical Performance

  2. Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test

    Time frame: blood collection up to 90 days from colonoscopy

    Clinical Performance

Sponsors and collaborators

Lead sponsor

New Day Diagnostics

Network

Registry information

Official study title

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

Acronym: CRC-DRAW

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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