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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193941
• Other study ID #: W20231218
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urologic Neoplasms
• Urothelial Carcinoma

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.