Urine VOC Investigation in Bladder Cancer Diagnosis

NCT05671289 | Completed

• 1 other identifier: XJTU1AF2022LSL-004
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urine volatile organic compounds composition of all urine samples

  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 Outcomes (1)

• Pathological diagnosis of bladder tumor patients enrolled

  Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university

Study Arms (2)

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

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

Interventions

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.

Healthy volunteers; Patients with confirmed bladder tumor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

35-45 ml early morning midstream urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinhai Fan, MD

  First affiliated hospital of Xian jiaotong university

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 4, 2023
• Study Start: November 10, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-01

Locations

CN (1)