Urine VOC Investigation in Bladder Cancer Diagnosis

NCT ID: NCT05671289

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-03-10

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

analysis of urine volatile organic compounds

Intervention Type DIAGNOSTIC_TEST

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.

analysis of urine volatile organic compounds

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinhai Fan, MD

Role: STUDY_DIRECTOR

First affiliated hospital of Xian jiaotong university

Locations

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First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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XJTU1AF2022LSL-004

Identifier Type: -

Identifier Source: org_study_id

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