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

Sun Yat-sen University

Status: Unknown

Conditions: Bladder Cancer

Treatments: Diagnostic Test: serum and urine metabolomics

Study type: Observational

Funder types: Other

Identifiers

NCT04966962

SysMU-diag1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

Bladder cancer

Description:

Patients who diagnosis with incident or recurrent bladder cancer

Treatment:

Diagnostic Test: serum and urine metabolomics

benign disease of urinary system

Description:

Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.

Treatment:

Diagnostic Test: serum and urine metabolomics