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Completed

NCT Number: NCT05742867

A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.

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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Morrisville, North Carolina, 27560, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must reside in Japan and able to speak/read Japanese for the interview/survey
  • Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):
  • ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
  • pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
  • Must not have received any treatment related to MIBC after radical cystectomy

Exclusion criteria

  • Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
  • Confirmed diagnosis of other primary cancers at the time of obtaining consent
  • Current participation in a MIBC clinical trial

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: Up to 1 year after radical cystectomy

    Median overall survival (years)

  2. 5-year survival rate

    Time frame: Up to 1 year after radical cystectomy

    Defined as the percentage of patients that are alive after 5 years

  3. Disease-free survival (DFS)

    Time frame: Up to 1 year after radical cystectomy

    Median disease-free survival (year)

  4. Probability of side effect-related treatment discontinuation

    Time frame: Up to 1 year after radical cystectomy

    Defined as the percent likelihood that a patient will stop treatment due to a side effect

  5. Number of participants who experience treatment side effects

    Time frame: Up to 1 year after radical cystectomy

    Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment

  6. Overall severity of side effects

    Time frame: Up to 1 year after radical cystectomy

    Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"

  7. Treatment Convenience

    Time frame: Up to 1 year after radical cystectomy

    Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)

  8. Treatment duration

    Time frame: Up to 1 year after radical cystectomy

    Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year

  9. Hospitalization

    Time frame: Up to 1 year after radical cystectomy

    Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week

  10. Frequency of outpatient consultations

    Time frame: Up to 1 year after radical cystectomy

    Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months

  11. Annual treatment costs

    Time frame: Up to 1 year after radical cystectomy

    Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan

Acronym: SNUGGLE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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