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Clinical Trials/JPRN-jRCT1031230091
JPRN-jRCT1031230091
Recruiting
未知

AN OBSERVATIONAL STUDY EVALUATING TREATMENT SITUATION OF ADJUVANT NIVOLUMAB FOR MUSCLE-INVASIVE UROTHELIAL CARCINOMA IN JAPAN - ANNIVERSARY

AKANO TOMOYOSHI0 sites400 target enrollmentMay 26, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Muscle invasive urothelial carcinoma
Sponsor
AKANO TOMOYOSHI
Enrollment
400
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 26, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Sponsor
AKANO TOMOYOSHI

Eligibility Criteria

Inclusion Criteria

  • 1\) Patients aged 18 years or older
  • 2\) Patients with histologically definitive diagnosis of MIUC at each study site and who received nivolumab after radical resection
  • 3\) Patients who present at least once to the study site after nivolumab treatment or who have survival data
  • 4\) In the case of a patient who is currently visiting a study site participating in the study, the patient must be fully informed of their enrollment in the study and provide written consent of his/her own free will after sufficient understanding.

Exclusion Criteria

  • Patients who did not meet any of the following criteria at the time of obtaining consent will not be included in this study.
  • 1\) Patients who underwent only partial resection for MIUC
  • 2\) Patients treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or BCG therapy from the time of radical resection of MIUC to the start of nivolumab
  • 3\) Those who received investigational drugs after being diagnosed with MIUC and before or administered nivolumab
  • 4\) Patients previously treated with immune checkpoint inhibitors prior to nivolumab treatment
  • 5\) Patients judged to be inappropriate for enrollment in this study by the investigator at each participating study site

Outcomes

Primary Outcomes

Not specified

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