Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
July 15, 2021 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
180
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients diagnosed with bladder cancer or benign.
disease of urinary system will be enrolled.
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bladder cancer
Patients who diagnosis with incident or recurrent bladder cancer
|
serum and urine samples will be collected for metabolomics analysis
|
|
benign disease of urinary system
Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.
|
serum and urine samples will be collected for metabolomics analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2021
Primary Completion (ANTICIPATED)
August 31, 2022
Study Completion (ANTICIPATED)
August 31, 2022
Study Registration Dates
First Submitted
July 9, 2021
First Submitted That Met QC Criteria
July 15, 2021
First Posted (ACTUAL)
July 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 19, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SysMU-diag1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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