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NCT Number: NCT07310446

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, 60010, United States

Location status: Recruiting

Location contact

Manish Bhuva, MD

CONTACT

[email protected]

8473824410

Manish Bhuva, MD

PRINCIPAL_INVESTIGATOR

About this study

The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. 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 pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of assay

    Time frame: 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.

Secondary outcomes

  1. ML Training

    Time frame: Through study completion to extend up to 24 months post LPI

    A portion of the samples will be used to train the ML algorithms and for assay development activities. Another purpose of the study is to collect samples to be used in Analytical Validation (Assay Verification) and system validation.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Jesus Merino Calvo

CONTACT

[email protected]

674945571

Sponsors and collaborators

Lead sponsor

Universal Diagnostics

Industry

Registry information

Official study title

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

Acronym: PROVE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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