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

NCT06193941 | Completed

• 1 other identifier: W20231218
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• RT-qPCR

  Urine exosomal RNA

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

Study Arms (3)

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

RT-qPCR DIAGNOSTIC_TEST

RT-qPCR

Case group （bladder cancer）; Control group （benigh）; Healthy people group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University

You may qualify if:

• Age ≥ 18 years with defined gender;
• Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.

You may not qualify if:

• Aged \<18 years;
• Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
• History of other malignant tumors
• Specimens with hemolytic conditions;
• Patients with incomplete, undocumented, and uncooperative data.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Fubing Wang, Doctor

  Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

CN (1)