Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits

January 5, 2024 updated by: Zhongnan Hospital
Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University

Description

Inclusion Criteria:

  1. Age ≥ 18 years with defined gender;
  2. Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.

Exclusion Criteria:

  1. Aged <18 years;
  2. Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
  3. History of other malignant tumors
  4. Specimens with hemolytic conditions;
  5. Patients with incomplete, undocumented, and uncooperative data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group （bladder cancer）
Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.
Diagnostic test: RT-qPCR
RT-qPCR
Control group （benigh）
Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.
Diagnostic test: RT-qPCR
RT-qPCR
Healthy people group
Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.
Diagnostic test: RT-qPCR
RT-qPCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RT-qPCR
Time Frame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.
Urine exosomal RNA
Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Fubing Wang, Doctor, Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W20231218

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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