Status:

UNKNOWN

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

Lead Sponsor:

Changhai Hospital

Conditions:

Bladder Cancer

Eligibility:

All Genders

18-99 years

Brief 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 transurethr...

Detailed Description

NMIBC at medium to high risk showcases a recurrence rate of 40.5% post-TURBT, thus necessitating frequent monitoring and bladder instillation. Among patients with medium to high-risk NMIBC, the prefer...

Eligibility Criteria

Inclusion

  • Participants aged ≥ 18 years and signed informed consent form.
  • Participants diagnosed with median to high risk NMIBC underwent TURBT and received BCG instillation therapy.

Exclusion

  • Participants with urinary tract infection
  • Antibiotic treatment within the last month
  • Immuno- /chemo- therapy within the past 6 months
  • Immunosuppressive therapy
  • Indwelling urinary catheter
  • Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder)
  • Participants with urothelial carcinoma accompanied by other malignancy.
  • Individuals unwilling to sign the consent form or unwilling to provide urine sample for test or quality of urine sample is poor.

Key Trial Info

Start Date :

December 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06153849

Start Date

December 1 2023

End Date

May 1 2025

Last Update

December 1 2023

Active Locations (1)

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Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433