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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05551052

Acronym

CRC-DRAW

Enrollment

196

Registered

2022-09-22

Start date

2022-09-08

Completion date

2027-12-31

Last updated

2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DIAGNOSTIC_TESTNext-Gen CRC Screening Test

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026