Actively Recruiting

Age: 18Years +
All Genders
ID06170177

Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

Led by IRCCS San Raffaele · Updated on 2023-12-14

4000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on patients who have undergone radical cystectomy, an operation to remove the entire bladder, to assess their quality of life and pathological state over time. The study aims to gain health insights that may benefit current and future patients and to improve scientific knowledge and diagnostic and treatment procedures related to this surgery. Participants will be followed for approximately 10 years starting from their surgery date. Data collection includes pre-hospitalization clinical information and symptoms, hospitalization details, and annual quality of life questionnaires administered through the participant's preferred communication method, such as phone, email, or home visits. The study is managed by the Urology Department staff who will securely record and transfer data into a dedicated database. Throughout the study, participants may be contacted yearly for follow-up assessments that gather clinical data and quality of life information. The primary outcomes measured include health benefits for participants and advancements in medical understanding related to radical cystectomy. The study continues annually until participants choose to stop responding or until death. Data privacy and good clinical practices are strictly followed during the entire observation period.

CONDITIONS

Brief Title

Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects underwent radical cystectomy
  • Older than 18 years
  • Ability to read and sign the informed consent
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Inability to read and sign the informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Hospitalization period

Participants undergo a radical cystectomy, which is an operation to remove the whole bladder.

1 hospitalization period

Long-term Monitoring

Duration - Approximately 10 years

Participants are followed for approximately 10 years after surgery with yearly quality of life questionnaires administered via phone call, email, or home address according to participant preference.

Annual follow-up contacts

Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, MI, Italy, 20132

Actively Recruiting

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Research Team

F

Francesco Montorsi, MD

G

Giusy Burgio, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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