Urine VOC Investigation in Bladder Cancer Diagnosis

Completed

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: analysis of urine volatile organic compounds

• Registration Number: NCT05671289
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The goal of this study to investigate the volatile organic compounds (VOCs) in the urine samples of both healthy individual and bladder cancer patients, using gas chromatography - mass spectrometry. Researchers aim to find a set of certain VOCs specific to bladder cancer and use this set to construct a diagnostic model that can help diagnosing bladder cancer. Participants will be asked to collect their early morning midstream urine in a predesignated container. Researchers will compare urine VOCs from bladder cancer patients and healthy individuals to see if there is any VOC whose concentration differ significantly among the two groups.

Detailed Description

Specifically, participants will be asked to collect 35-45 ml of their early morning midstream urine sample in a predesignated polytetrafluoroethylene bottle. Researcher will collect participants' health information, including their: 1)smoking history; 2)comorbidity; 3) history of past urological procedure; 4)medication; 5)pathology diagnosis after surgery, if participants have bladder cancer.

Study Timeline

• Study Start: 2022-11-10
• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-04
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• bladder tumor confirmed by cystoscopy and radiology
• women of childbearing age with negative urine pregnancy test result
• willing to participate in this trial and sign the informed consent form

Exclusion Criteria

• patient with 1) uncontrollable urinary tract infection; 2) severe systemic disease; 3) history of malignancy within the past 5 years; 4) pregnancy or lactation
• patient involved in other clinical trials
• other situations researcher considered to be ineligible for this trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	analysis of urine volatile organic compounds	Individuals with no known disease and normal urinalysis. Age ranging from 18 to 80 years old. Women of childbearing age should have negative urine pregnancy test.
Patients with confirmed bladder tumor	analysis of urine volatile organic compounds	Patients with bladder tumor, confirmed by cystoscopy and radiology. Age ranging from 18 to 80 years old. Women of childbearing age should have negative urine pregnancy test.

Primary Outcome Measures

Name	Time	Method
Urine volatile organic compounds composition of all urine samples	immediately after GC-MS analysis has been finished	Data derived from mass spectrums of GC-MS measurement of VOC components in urine samples, including VOC components identified comparing obtained data to those in public GC-MS database and the absolute concentration of VOCs identified.

Secondary Outcome Measures

Name	Time	Method
Pathological diagnosis of bladder tumor patients enrolled	Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university	Staging of bladder cancer using American Joint Committee on Cancer (AJCC) TNM system and histology of tumor tissue will be collected, if patient has received surgery during hospitalization. Concerning bladder tumor patients only.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China