Urine VOC Investigation in Bladder Cancer Diagnosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of Urine Volatile Organic Compounds as Novel Diagnostic Biomarker in Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: analysis of urine volatile organic compounds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with confirmed bladder tumor<br>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. | Diagnostic Test: analysis of urine volatile organic compounds<br>* gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.<br>|
| Healthy volunteers<br>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. | Diagnostic Test: analysis of urine volatile organic compounds<br>* gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine volatile organic compounds composition of all urine samples | 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. | immediately after GC-MS analysis has been finished | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological diagnosis of bladder tumor patients enrolled | 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. | Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urine, bladder cancer, GS-MS, volatile organic compounds