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

Part of paid clinical trials in Lake Barrington, Illinois.

Sponsor
Universal Diagnostics
Study ID
NCT07310446
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 84 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
6,500 participants (estimated)

Arms

  • Arm: Arm A
    Patients newly diagnosed with CRC who have not yet had treatment or surgery.
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Gastroenterology and Internal Medicine SpecialistsLake BarringtonIllinois60010
Manish Bhuva, MD
8473824410
Manish Bhuva, MD (PRINCIPAL_INVESTIGATOR)

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