Status:

UNKNOWN

a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients

Lead Sponsor:

Yonsei University

Conditions:

Muscle-Invasive Bladder Carcinoma

Eligibility:

All Genders

19+ years

Brief Summary

This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical...

Detailed Description

The treatment in this study is one of the standard treatments suggested by the NCCN guidelines. Bladder is preserved when neoadjuvant concurrent chemoradiotherapy is performed after transurethral rese...

Eligibility Criteria

Inclusion

  • Patients older than 19 years old
  • Clinically or histologically diagnosed urothelial carcinoma bladder cancer
  • Patients who satisfy all of the following conditions with bladder cancer stage T2-4a, N0-1 according to 8th edition of American Joint Committee on Cancer
  • Muscle invasive bladder cancer confirmed by cystoscopy
  • Stage T2-4a, N0-1 in CT or MRI
  • Performance status 0 or 1 based on ECOG
  • Patients agreed to provide the tissue sample obtained from TURB
  • Diseases can be evaluated according to RECIST Version 1.1
  • Patients who voluntarily agreed to informed consent

Exclusion

  • Patients with distant metastasis
  • Patients with uncontrolled viral infection (HIV, HBV, HCV)
  • Patient who are pregnant, or have possibility of pregnancy and are on lactating
  • Hypersensitivity or history of allergic to the drug being used
  • Patients with cerebrovascular disease, complications, and infections that are not medically controlled
  • Patients with history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
  • Those who are taking drugs that can cause drug interactions with chemotherapy
  • Patients who withdraw consent

Key Trial Info

Start Date :

January 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04686149

Start Date

January 1 2021

End Date

December 1 2024

Last Update

December 28 2020

Active Locations (1)

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1

Yonsei Severance Hospital

Seoul, South Korea