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

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07310446

Acronym

PROVE

Enrollment

6500

Registered

2025-12-30

Start date

2023-07-31

Completion date

2027-07-31

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal, screening

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 84 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
ML Training	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.

Countries

United States

Contacts

Primary ContactAntonio Jesus Merino Calvo

antonio.merino@universaldx.com674945571

Outcome results