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Analyzing the Urine During BCG Instillation in Bladder Cancer Patients for Disease Followup - Trial NCT06153849

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NCT06153849
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06153849
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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

Study Focus

Bladder Cancer

urine sample collection

Observational

diagnostic test

Sponsor & Location

Changhai Hospital

Shanghai, China

Timeline & Enrollment

N/A

Dec 01, 2023

May 01, 2025

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 bladder
Malignant neoplasm: Bladder, unspecified
Malignant neoplasm: Dome of bladder
Malignant neoplasm: Overlapping lesion of bladder
Malignant neoplasm: Lateral wall of bladder

Data Source

ClinicalTrials.gov

NCT06153849

Non-Device Trial