Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: serum and urine metabolomics


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder cancer<br>Patients who diagnosis with incident or recurrent bladder cancer | Diagnostic Test: serum and urine metabolomics<br>* serum and urine samples will be collected for metabolomics analysis<br>|
| benign disease of urinary system<br>Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia. | Diagnostic Test: serum and urine metabolomics<br>* serum and urine samples will be collected for metabolomics analysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, metabolomics