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

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: serum and urine metabolomics

• Registration Number: NCT04966962
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-19
• Study Start: 2021-09-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Bladder cancer group:

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with incident or recurrent bladder cancer

Control group

1. Any male or female patient aged 18 or older
2. Able to provide serum and urine specimen before treatment
3. Diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.

Exclusion Criteria

1. Kidney and liver dysfunction.
2. Incomplete clinical information and laboratory test result
3. Tumor-related treatment was received preoperatively
4. Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder cancer	serum and urine metabolomics	Patients who diagnosis with incident or recurrent bladder cancer
benign disease of urinary system	serum and urine metabolomics	Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.

Primary Outcome Measures

Name	Time	Method
Sensitivity	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	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