Urine VOC Investigation in Bladder Cancer Diagnosis

Xi'an Jiaotong University

Status: Completed

Conditions: Bladder Cancer

Treatments: Diagnostic Test: analysis of urine volatile organic compounds

Study type: Observational

Funder types: Other

Identifiers

NCT05671289

XJTU1AF2022LSL-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

77 participants in 2 patient groups

Patients with confirmed bladder tumor

Description:

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.

Treatment:

Diagnostic Test: analysis of urine volatile organic compounds

Healthy volunteers

Description:

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.

Treatment:

Diagnostic Test: analysis of urine volatile organic compounds