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NCT Number: NCT05671289

Urine VOC Investigation in Bladder Cancer Diagnosis

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analysis of urine volatile organic compounds

Diagnostic Test

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

Primary outcomes

  1. Urine volatile organic compounds composition of all urine samples

    Time frame: 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 outcomes

  1. Pathological diagnosis of bladder tumor patients enrolled

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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