Urine VOC Investigation in Bladder Cancer Diagnosis

First Affiliated Hospital Xi'an Jiaotong University77 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer

Interventions

analysis of urine volatile organic compounds

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: immediately after GC-MS analysis has been finished

Secondary Outcomes

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.

Time frame: Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university