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 · tracked via the Priya Life Science USA tracker

Sponsor

Universal Diagnostics

Phase

Observational

Started

2023-07-31

Last updated

2025-12-30

Condition(s) studied

Colorectal Cancer

Study 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.

Eligibility

Sex

ALL

Min age

45 Years

Max age

84 Years

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

Primary outcome measure(s)

Development of assay — Baseline
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.

Trial sites (1)

Facility	City	Region	Status
Gastroenterology and Internal Medicine Specialists	Lake Barrington	Illinois	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07310446 on ClinicalTrials.gov ↗ ← All trials in the USA