Recruiting NCT06170177

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

— Observational Muscle-Invasive Bladder Carcinoma Muscle Invasive Bladder Urothelial Carcinoma Bladder Cancer TNM Staging Bladder Cancer Stage IIa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Radical Cystectomy.
Who it may be relevant to: Registry conditions: Muscle-Invasive Bladder Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Bladder Cancer TNM Staging, Bladder Cancer Stage IIa. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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.]
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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Italy · 1 center

IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT06170177 · 2012/Vescica

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗