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

Completed

• Conditions: Bladder Cancer; Urothelial Carcinoma
• Interventions: Diagnostic Test: RT-qPCR

• Registration Number: NCT06193941
• Lead Sponsor: Zhongnan Hospital

Brief 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.

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 Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy people group	RT-qPCR	Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.
Control group （benigh）	RT-qPCR	Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.
Case group （bladder cancer）	RT-qPCR	Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected.

Primary Outcome Measures

Name	Time	Method
RT-qPCR	Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.	Urine exosomal RNA

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China