Muscle-Invasive Bladder CarcinomaNCT06170177
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
An observational study of Muscle-Invasive Bladder Carcinoma and Muscle Invasive Bladder Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Observational study on the quality of life and pathological state of patients underwent radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Bladder Cancer TNM Staging
- What is being tested?
- Radical Cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2013to Feb 2063
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with muscle-invasive bladder cancer underwent radycal cystectomy
Who may be able to join
- subjects underwent radical cystectomy
- > 18 years old
- Ability to read and sign the informed consent
Who cannot join
- Age <18 years
- Inability to read and sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Francesco Montorsi, MD, +390226437286, montorsi.francesco@hsr.it
Giusy Burgio, MSc, +390226436764, burgio.giusy@hsr.it
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- Radical Cystectomy
- Keywords
- Radical Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical CystectomyProcedure or surgery
A radical cystectomy is an operation to remove the whole bladder
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent radical cystectomy | Not described Receives: Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start4 Feb 2013
- Primary completionFeb 2063 (estimated)
- Study completionFeb 2063 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
- Investigators
- Francesco Montorsi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170177
- Sponsor's protocol ID
- 2012/Vescica
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No