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

NCT ID: NCT04966962

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bladder cancer

Patients who diagnosis with incident or recurrent bladder cancer

serum and urine metabolomics

Intervention Type DIAGNOSTIC_TEST

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 metabolomics

Intervention Type DIAGNOSTIC_TEST

serum and urine samples will be collected for metabolomics analysis

Interventions

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serum and urine metabolomics

serum and urine samples will be collected for metabolomics analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The Seventh Affiliated Hospital of Sun Yat-sen University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Central Contacts

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Hao Chen

Role: CONTACT

+86-02034078960

Other Identifiers

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SysMU-diag1

Identifier Type: -

Identifier Source: org_study_id

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