CRC Detection Reliable Assessment With Blood

NCT05551052 | Active Not Recruiting

• 1 other identifier: SPR0033P
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colorectal Cancer; Adenomas Colon; Colon Cancer; Rectal Cancer; Colon Neoplasm; Colon Lesion; Colon Disease; Colon Polyp; Polyps; Adenoma; Rectal Diseases; Rectal Polyp; Gastrointestinal Neoplasms; Intestinal Neoplasms; Colonic Diseases, Functional; Intestinal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  blood collection up to 90 days from colonoscopy

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

  blood collection up to 90 days from colonoscopy

Study Arms (1)

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

Interventions

Next-Gen CRC Screening Test DIAGNOSTIC_TEST

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

Next-Gen CRC Screening Test

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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).
• Previous personal history of CRC or precancerous lesions
• Positive result from non-invasive screening test within the associated recommended intervals:
• 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:
• 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:
• 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

Sponsors & Collaborators

• New Day Diagnostics: lead

Study Sites (3)

Gastro SB

Chula Vista, California, 91910, United States

Location

SDG Clinical Research

San Diego, California, 92103, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be de-identified and used to validate the performance characteristics of the Next-Gen CRC Screening Test. Blood samples may also be used for future research and development, feasibility and validation.

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Colonic Diseases; Colonic Polyps; Polyps; Adenoma; Rectal Diseases; Gastrointestinal Neoplasms; Intestinal Neoplasms; Colonic Diseases, Functional; Intestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)