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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04966962
Enrollment
180
Registered
2021-07-19
Start date
2021-09-01
Completion date
2022-08-31
Last updated
2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, metabolomics

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.

Interventions

DIAGNOSTIC_TESTserum and urine metabolomics

serum and urine samples will be collected for metabolomics analysis

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
The Seventh Affiliated Hospital of Sun Yat-sen University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity1 yearMeasurement the sensitivity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Specificity1 yearMeasurement the specificity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system

Contacts

Primary ContactHao Chen
chenh585@mail2.sysu.edu.cn+86-02034078960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026