Clinical trial NCT05671289: Urine VOC Investigation in Bladder Cancer Diagnosis
Official title: Investigation of Urine Volatile Organic Compounds as Novel Diagnostic Biomarker in Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: volatile organic compounds
urine
bladder cancer
GS-MS
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with confirmed bladder tumor, present in first affiliated hospital of Xi'an jiaotong university during the recruitment phase, are recruited. Healthy volunteers are recruited outside the hospital with invitations to participate.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine volatile organic compounds composition of all urine samples
timeFrame: immediately after GC-MS analysis has been finished
Secondary outcomes:
measure: Pathological diagnosis of bladder tumor patients enrolled
timeFrame: Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First affiliated hospital of Xian jiaotong university
name: Jinhai Fan, MD
role: STUDY_DIRECTOR
References: