Bladder CancerNCT04966962
Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
An observational study of Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- serum and urine metabolomics
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Aug 2022
- 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
- Adult, Older adult
Study population: Patients diagnosed with bladder cancer or benign. disease of urinary system will be enrolled.
Who may be able to join
- Bladder cancer group:
- Any male or female patient aged 18 or older
- Able to provide serum and urine specimen before treatment
- Diagnosis with incident or recurrent bladder cancer
- Control group
- Any male or female patient aged 18 or older
- Able to provide serum and urine specimen before treatment
- Diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.
Who cannot join
- Kidney and liver dysfunction.
- Incomplete clinical information and laboratory test result
- Tumor-related treatment was received preoperatively
- Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors
Trial locations and contacts
No sites are listed yet.
About this study
Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.
Read the detailed description
Early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. Currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. Metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. This is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. Commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (NMR), gas chromatography mass spectrometry (GC-MS), and liquid chromatography mass spectrometry （LC-MS）. The diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.
- Conditions
- Bladder Cancer
- Being tested
- serum and urine metabolomics
- Keywords
- bladder cancer, metabolomics
- 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.
serum and urine metabolomicsDiagnostic test
serum and urine samples will be collected for metabolomics analysis
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer | Patients who diagnosis with incident or recurrent bladder cancer Receives: Diagnostic Test: serum and urine metabolomics | |
| benign disease of urinary system | Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia. Receives: Diagnostic Test: serum and urine metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Measurement the sensitivity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Measured: 1 year
Specificity
Measurement the specificity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, The Seventh Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Jian Huang, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966962
- Sponsor's protocol ID
- SysMU-diag1
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
- ClinicalTrials.gov ID
- NCT04966962
- Acronym / sponsor ID
- SysMU-diag1
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, The Seventh Affiliated Hospital of Sun Yat-sen University
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.
Detailed description
Early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. Currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. Metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. This is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. Commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (NMR), gas chromatography mass spectrometry (GC-MS), and liquid chromatography mass spectrometry （LC-MS）. The diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer | – | Diagnostic Test: serum and urine metabolomicsPatients who diagnosis with incident or recurrent bladder cancer |
| benign disease of urinary system | – | Diagnostic Test: serum and urine metabolomicsPatients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bladder cancer or benign. disease of urinary system will be enrolled.
Key inclusion criteria (8 listed)
- Any male or female patient aged 18 or older
- Able to provide serum and urine specimen before treatment
- Diagnosis with incident or recurrent bladder cancer
- Control group
- Any male or female patient aged 18 or older
Key exclusion criteria (4 listed)
- Kidney and liver dysfunction.
- Incomplete clinical information and laboratory test result
- Tumor-related treatment was received preoperatively
- Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors
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 |
|---|---|---|
| serum and urine metabolomicsserum and urine samples will be collected for metabolomics analysis | Diagnostic test | Bladder cancer, benign disease of urinary system |
Primary outcome
Sensitivity
Time frame: 1 year
Measurement the sensitivity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Specificity
Time frame: 1 year
Measurement the specificity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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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.
Jian Huang, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen (+86-02034078960, chenh585@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 19 Jul 2021.