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

NCT06170177 | Recruiting

• 1 other identifier: 2012/Vescica
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Patients underwent radical cystectomy

Procedure: Radical Cystectomy

Interventions

Radical Cystectomy PROCEDURE

A radical cystectomy is an operation to remove the whole bladder

Patients underwent radical cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with muscle-invasive bladder cancer underwent radycal cystectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease Progression

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Francesco Montorsi, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Montorsi, MD

CONTACT

+390226437286; montorsi.francesco@hsr.it

Giusy Burgio, MSc

CONTACT

+390226436764; burgio.giusy@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: December 14, 2023
• Study Start: February 4, 2013
• Primary Completion (Estimated): February 1, 2063
• Study Completion (Estimated): February 1, 2063
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)