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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
- ClinicalTrials.gov ID
- NCT06170177
- Acronym / sponsor ID
- 2012/Vescica
- 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
- Keywords
- Radical Cystectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- Feb 2063 (estimated)
- Study completion
- Feb 2063 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent radical cystectomy | – | Procedure: Radical Cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with muscle-invasive bladder cancer underwent radycal cystectomy
Key inclusion criteria (3 listed)
- subjects underwent radical cystectomy
- > 18 years old
- Ability to read and sign the informed consent
Key exclusion criteria (2 listed)
- Age <18 years
- Inability to read and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical CystectomyA radical cystectomy is an operation to remove the whole bladder | Procedure or surgery | Patients underwent radical cystectomy |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Montorsi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma and Muscle Invasive Bladder Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Montorsi, MD (+390226437286, montorsi.francesco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.