Clinical trial NCT06170177: Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Official title: Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Muscle-Invasive Bladder Carcinoma
Muscle Invasive Bladder Urothelial Carcinoma
Bladder Cancer TNM Staging
Bladder Cancer Stage IIa
Bladder Cancer Stage IIb
Bladder Cancer Stage IV
Bladder Leiomyosarcoma
Bladder Cancer
Bladder Cancer Stage II
Bladder Cancer Stage IIIa
Bladder Cancer Stage IIIb
Bladder Cancer Stage IIIc
Bladder Urothelial Carcinoma
Progression, Disease
Urinary Diversion
Neobladder
Radical Cystectomy
Keywords: Radical Cystectomy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with muscle-invasive bladder cancer underwent radycal cystectomy

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: obtain health benefit for the patients themselves and for future patients underwent radical cystectomy
timeFrame: 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.
measure: improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Francesco Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References: