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

Bladder Archive: Observational 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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Muscle-Invasive Bladder Carcinoma; Radical Cystectomy; Urinary Diversion; Bladder Urothelial Carcinoma; Progression, Disease; Bladder Cancer Stage II; Bladder Cancer Stage IV; Muscle Invasive Bladder Urothelial Carcinoma; Neobladder; Bladder Cancer TNM Staging; Bladder Cancer Stage IIa; Bladder Cancer Stage IIb; Bladder Leiomyosarcoma; Bladder Cancer Stage IIIa; Bladder Cancer Stage IIIb; Bladder Cancer Stage IIIc
• Intervention / Treatment: Procedure: 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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Francesco Montorsi, MD; Phone Number: +390226437286; Email: montorsi.francesco@hsr.it
• Study Contact Backup: Name: Giusy Burgio, MSc; Phone Number: +390226436764; Email: burgio.giusy@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Francesco Montorsi, MD; Phone Number: +390226437286; Email: montorsi.francesco@hsr.it
      • Contact: Giusy Burgio, MSc; Phone Number: +390226436764; Email: burgio.giusy@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with muscle-invasive bladder cancer underwent radycal cystectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent radical cystectomy	Procedure: Radical Cystectomy; A radical cystectomy is an operation to remove the whole bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Francesco Montorsi, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2013
• Primary Completion (Estimated): February 1, 2063
• Study Completion (Estimated): February 1, 2063

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radical Cystectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Disease Attributes; Sarcoma; Neoplasms, Muscle Tissue; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Progression; Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Leiomyosarcoma
• Other Study ID Numbers: 2012/Vescica

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No