Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
1 other identifier
observational
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJuly 19, 2021
July 1, 2021
12 months
July 9, 2021
July 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Bladder cancer
Patients who diagnosis with incident or recurrent bladder cancer
benign disease of urinary system
Patients who clinically diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.
Interventions
serum and urine samples will be collected for metabolomics analysis
Eligibility Criteria
Patients diagnosed with bladder cancer or benign. disease of urinary system will be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Huang, MD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
July 19, 2021
Study Start
September 1, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
July 19, 2021
Record last verified: 2021-07