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Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer

NCT06509919 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2024-12-27

No results posted yet for this study

Summary

The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood draw

Before undergoing a prostate biopsy, participants will have about 10 mLs of venous blood drawn. Blood will be sent to Geneseeq Technology Inc. for whole genome high-throughput sequencing of plasma cfDNA.

Sponsors & Collaborators

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Jiangsu Provincial People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Zhongda Hospital

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Shanghai Changzheng Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509919 on ClinicalTrials.gov