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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170177
• Other study ID #: 2012/Vescica
• Status: Recruiting
• Start date: February 4, 2013
• Est. completion date: February 2063

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Francesco Montorsi, MD
• Phone: +390226437286
• Email: montorsi.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: February 2063
• Est. primary completion date: February 2063
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Cancer Stage II
• Bladder Cancer Stage IV
• Bladder Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell
• Disease Progression
• Leiomyosarcoma
• Muscle-Invasive Bladder Carcinoma
• Neobladder
• Progression, Disease
• Radical Cystectomy
• Urinary Bladder Neoplasms
• Urinary Diversion

Intervention

Procedure:
• Radical Cystectomy
A radical cystectomy is an operation to remove the whole bladder

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obtain health benefit for the patients themselves and for future patients underwent radical cystectomy	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.	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.
Primary	improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient	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.	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.