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CRC Detection Reliable Assessment With Blood | Clinical Trials | Clareo Health

ACTIVE_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

NCT05551052•New Day Diagnostics

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant is 45 years of age or older at time of enrollment.

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).
•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 more criteria

Locations (3)

Gastro SB

Chula Vista, California, United States

SDG Clinical Research

San Diego, California, United States

Medical Associates Research Group

San Diego, California, United States

Key Dates

Start Date

September 8, 2022

Primary Completion Date

October 31, 2027

Completion Date

December 31, 2027

Last Updated

May 29, 2025

Enrollment

196

ACTUAL participants

Conditions

Colorectal CancerAdenomas ColonColon CancerRectal CancerColon NeoplasmColon LesionColon DiseaseColon PolypPolypsAdenomaRectal DiseasesRectal PolypGastrointestinal NeoplasmsIntestinal NeoplasmsColonic Diseases, FunctionalIntestinal Disease

Interventions

Next-Gen CRC Screening Test

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CRC Detection Reliable Assessment With Blood

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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