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NCT06153849Not yet recruiting

Analyzing the Urine During BCG Instillation in Bladder Cancer Patients for Disease Followup

Analyzing the Urine Microbiome and Chromosomal Instability by Whole Genome Sequening in Bladder Cancer Patients During BCG Instillation for Disease Follow-up
Changhai HospitalClinicalTrials.govdiagnostic test
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
urine sample collection
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Changhai Hospital
Location
Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2023
End date
May 01, 2025
Enrollment
100 participants
Primary outcome

Correlation between urinary microbiome and BCG instillation efficacy.

Summary

Bacillus Calmette-Guerin (BCG) has been extensively utilized in intravesical instillation
 therapy for patients with medium to high risk non-muscle invasive bladder cancer (NMIBC)
 following transurethral resection of bladder tumor (TURBT). Nevertheless, the efficacy of BCG
 instillation can fluctuate between patients, with 40.5% experiencing disease recurrence
 during BCG therapy. The effectiveness of BCG instillation may be linked to the urinary
 microbiome and immune microenvironment. Additionally, small residual lesions post-TURBT could
 also result in bladder cancer recurrence. Low coverage whole genome sequencing (LC-WGS) can
 be used to detect the urinary microbiome and chromosomal instability (CIN), making it
 feasible to predict the recurrence or progression of bladder cancer during BCG instillation
 therapy. Here, we intend to evaluate the feasibility of detecting urine samples of bladder
 cancer patients receiving BCG instillation to predict the bladder cancer recurrence.

ICD-10 classifications
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06153849
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06153849 through Pure Global AI's free database. This phase not specified trial is sponsored by Changhai Hospital and is currently Not yet recruiting. The study focuses on Bladder Cancer. Target enrollment is 100 participants.

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