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CompletedNCT06193941Updated Jan 9, 2024

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

An observational study in Bladder Cancer and Urothelial Carcinoma, sponsored by Zhongnan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Zhongnan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Bladder Cancer
  • Urothelial Carcinoma

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In context

Urologic Neoplasms

143 studies on the registry are indexed under Urologic Neoplasms; 42 are open to participants now.

This study's enrollment of 400 is above the median of 200 across 33 observational studies indexed under Urologic Neoplasms.

Browse Urologic Neoplasms studies →

Lead sponsor

Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • Case group (bladder cancer)

    Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.

    Diagnostic Test: RT-qPCR

  • Control group (benigh)

    Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.

    Diagnostic Test: RT-qPCR

  • Healthy people group

    Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.

    Diagnostic Test: RT-qPCR

Interventions

  • Diagnostic testRT-qPCR

    RT-qPCR

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What researchers measure

Primary outcomes

  1. RT-qPCR

    Urine exosomal RNA

    Time frame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.

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Study locations

1 site
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06193941
Lead sponsor
Zhongnan Hospital
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Jun 1, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Jan 9, 2024

Study contacts

Fubing Wang, Doctor
principal investigator · Wuhan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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