Urine VOC Investigation in Bladder Cancer Diagnosis

April 2, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with confirmed bladder tumor
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
gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.
Healthy volunteers
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
gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately after GC-MS analysis has been finished

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Jinhai Fan, MD, First Affiliated Hospital of Xian Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

March 10, 2023

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSL-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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