CRC Detection Reliable Assessment With Blood (CRC-DRAW)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Neoplasms; Colonic Diseases, Functional; Intestinal Neoplasms; Rectal Diseases; Colorectal Cancer; Adenoma; Rectal Cancer; Polyps; Colon Cancer; Colon Disease; Colon Polyp; Intestinal Disease; Colon Lesion; Colon Neoplasm; Adenomas Colon; Rectal Polyp
• Intervention / Treatment: Diagnostic test: Next-Gen CRC Screening Test

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.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Gastro SB
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
    • San Diego, California, United States, 92103
      • SDG Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Next-Gen CRC Screening Test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for CRC of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy
Specificity for CRC of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy
Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test	Clinical Performance	blood collection up to 90 days from colonoscopy

Collaborators and Investigators

• Sponsor: New Day Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms; Colonic Diseases; Colonic Diseases, Functional; Colorectal Neoplasms; Colonic Neoplasms; Gastrointestinal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Adenoma; Digestive System Neoplasms; Polyps; Rectal Diseases
• Other Study ID Numbers: SPR0033P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No