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NCT06153849

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

Status unknown Last updated 1 December 2023
What this trial tests

trial testing urine sample collection in Bladder Cancer in 100 participants. Status unknown.

Timeline
1 December 2023
Primary endpoint
1 December 2024
1 May 2025

Quick facts

Lead sponsorChanghai Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date1 December 2023
Primary completion1 December 2024
Estimated completion1 May 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Changhai Hospital

Who can join

Adults 18 to 99, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Role of Tumor and Host Microbiome on Immunotherapy Response in Urologic Cancers.
    Pfail J, Drobner J, Doppalapudi K, Saraiya B, et al · · 2024 · cited 6× · PMID 38846356 · DOI 10.33696/cancerimmunol.6.078
  2. Decoding Microbiota in Genitourinary Oncology: Biological Mechanisms and Clinical Implications-A Narrative Review.
    Caramella I, Abeni C, Cherri S, Ogliosi C, et al · · 2026 · PMID 41681968 · DOI 10.3390/cancers18030497

Verify or expand the search:

Other trials of urine sample collection

Trials testing the same drug.

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

Other Changhai Hospital trials

Trials by the same sponsor.

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Data sources for this page

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