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

NCT ID: NCT06193941

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-01

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.

Conditions

Bladder Cancer; Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Case group （bladder cancer）

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

RT-qPCR

Intervention Type: DIAGNOSTIC_TEST

RT-qPCR

Control group （benigh）

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

RT-qPCR

Intervention Type: DIAGNOSTIC_TEST

RT-qPCR

Healthy people group

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

RT-qPCR

Intervention Type: DIAGNOSTIC_TEST

RT-qPCR

Interventions

RT-qPCR

RT-qPCR

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fubing Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

W20231218

Identifier Type: -

Identifier Source: org_study_id