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Urine VOC Investigation in Bladder Cancer Diagnosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05671289
Enrollment
77
Registered
2023-01-04
Start date
2022-11-10
Completion date
2023-03-10
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

volatile organic compounds, urine, bladder cancer, GS-MS

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.

Interventions

DIAGNOSTIC_TESTanalysis of urine volatile organic compounds

gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urine volatile organic compounds composition of all urine samplesimmediately after GC-MS analysis has been finishedData 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

MeasureTime frameDescription
Pathological diagnosis of bladder tumor patients enrolledImmediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong universityStaging 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026