Bladder CancerNCT05671289
Urine VOC Investigation in Bladder Cancer Diagnosis
An observational study of Bladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- analysis of urine volatile organic compounds
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 10 Mar 2023
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- analysis of urine volatile organic compounds
- Keywords
- volatile organic compounds, urine, bladder cancer, GS-MS
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of urine volatile organic compoundsDiagnostic test
gas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: analysis of urine volatile organic compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after GC-MS analysis has been finished
Secondary outcomes (1)
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.
Measured: Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start10 Nov 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhai Fan, MD, Study director, First affiliated hospital of Xian jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671289
- Sponsor's protocol ID
- XJTU1AF2022LSL-004
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Urine Volatile Organic Compounds as Novel Diagnostic Biomarker in Bladder Cancer
- ClinicalTrials.gov ID
- NCT05671289
- Acronym / sponsor ID
- XJTU1AF2022LSL-004
- Conditions
- Bladder Cancer
- Keywords
- volatile organic compounds, urine, bladder cancer, GS-MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed bladder tumor | – | Diagnostic Test: analysis of urine volatile organic compoundsPatients 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. |
| Healthy volunteers | – | Diagnostic Test: analysis of urine volatile organic compoundsIndividuals 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of urine volatile organic compoundsgas chromatography - mass spectrometry will be used to assess the composition of VOCs in urine samples of all participants. | Diagnostic test | Healthy volunteers, Patients with confirmed bladder tumor |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhai Fan, MD study director
First affiliated hospital of Xian jiaotong university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine volatile organic compounds composition of all urine samples (time frame: immediately after GC-MS analysis has been finished). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.