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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06193941
Other study ID # W20231218
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2023

Study information

Verified date December 2023
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
RT-qPCR
RT-qPCR

Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary RT-qPCR Urine exosomal RNA Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.
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