Urine VOC Investigation in Bladder Cancer Diagnosis

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05671289
• Other study ID #: XJTU1AF2022LSL-004
• Status: Completed
• Start date: November 10, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pathological diagnosis of bladder tumor patients enrolled	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