Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance

NCT07310446 | Recruiting

• 1 other identifier: CRC-US-002
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Conditions

Colorectal Cancer

Keywords

colorectal; screening

Outcome Measures

Primary Outcomes (1)

• Development of assay

  The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.

  Baseline

Secondary Outcomes (1)

• ML Training

  Through study completion to extend up to 24 months post LPI

Study Arms (2)

Arm A

Patients newly diagnosed with CRC who have not yet had treatment or surgery.

Arm B

People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy.

Eligibility Criteria

• Age: 45 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prevalent colorectal cancer and people undergoing screening for colorectal cancer

You may qualify if:

• Arm A: Diagnosed with CRC
• Arm B: Undergoing screening with colonoscopy for CRC

You may not qualify if:

• Arm A: Undergoing treatment for CRC,
• Arm B: Past history of CRC

Sponsors & Collaborators

• Universal Diagnostics: lead

Study Sites (1)

Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, 60010, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Antonio Jesus Merino Calvo

CONTACT

674945571; antonio.merino@universaldx.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 30, 2025
• Study Start: July 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)