Recruiting

Observational Study

Sponsor:

Universal Diagnostics

Code:

NCT07310446

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07310446

Start date

Jul 31, 2023

Status verified date

Dec, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

6500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Development of assay [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Antonio Jesus Merino Calvo

674945571antonio.merino@universaldx.com

Locations

Gastroenterology and Internal Medicine Specialists

Recruiting

Lake Barrington, Illinois, United States, 60010

Contacts

Manish Bhuva, MD

8473824410prove@universaldx.com

Principal Investigator:

Manish Bhuva, MD

More Information

Sponsor

Universal Diagnostics

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • colorectal
  • screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Universal Diagnostics on 2025-12-30.