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NCT Number: NCT06170177

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

Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

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Key information

Conditions

Muscle-Invasive Bladder Carcinoma Bladder Cancer Bladder Cancer Stage II Bladder Cancer Stage IIIa Bladder Cancer Stage IIIb Bladder Cancer Stage IIIc Bladder Cancer Stage IIa Bladder Cancer Stage IIb Bladder Cancer Stage IV Bladder Cancer TNM Staging Bladder Leiomyosarcoma Bladder Urothelial Carcinoma Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle Invasive Bladder Urothelial Carcinoma Neobladder Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Progression, Disease Radical Cystectomy Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Diversion Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

The data entered will concern:

  • period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
  • hospitalization period with all its related data
  • questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects underwent radical cystectomy
  • > 18 years old
  • Ability to read and sign the informed consent

Exclusion criteria

  • Age <18 years
  • Inability to read and sign the informed consent

Treatment and study plan

Radical Cystectomy

Procedure

A radical cystectomy is an operation to remove the whole bladder

Primary outcomes

  1. obtain health benefit for the patients themselves and for future patients underwent radical cystectomy

    Time frame: Baseline and Follow-up. 1 Annual follow-up until the patient decides to stop providing follow-up responses or until the date of death from any cause.

    All patients, before underwent radical cystectomy, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history.

  2. improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient

    Time frame: Baseline and Follow-up. 1 Annual follow-up until the patient decides to stop providing follow-up responses or until the date of death from any cause.

    Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Montorsi, MD

CONTACT

[email protected]

+390226437286

Giusy Burgio, MSc

CONTACT

[email protected]

+390226436764

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2063
Study completion
2063
First posted
Dec 14, 2023
Registry last updated
Dec 14, 2023

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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