An observational study in Muscle-Invasive Bladder Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma and Bladder Cancer TNM Staging, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by IRCCS San Raffaele · Observational
Among 136 studies in Urinary Bladder Neoplasms with a site in Italy — 34 open to participants now, 53 under way, 17 of them phase 3. Urinary Bladder Neoplasms · Italy.
Among the 136 studies in Urinary Bladder Neoplasms with a site in Italy, this one is the 3rd largest by planned enrollment of the 26 observational ones that give a count, is one of 4 that started in 2013, is one of 26 observational ones, reaches primary completion later than 51 of the 52 other live ones, and was the 105th registered.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →34 of the 136 studies in Urinary Bladder Neoplasms with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →136 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 4 started in 2013.
Median enrollment 196 across the 110 interventional studies, 460 across the 26 observational. Of the 71 that completed or were terminated, 29 (41%) have results posted.
81 of 136 have an industry lead sponsor. The 10 most frequent:
IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
IRCCS San Raffaele has 4 studies filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
16 of the studies in Urinary Bladder Neoplasms with a site in Italy that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
| NCT07391137S. Andrea HospitalCRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC | 2026-11-01 |
| NCT07750470University Hospital of FerraraDiagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer | 2026-12 |
Among the 136 studies in Urinary Bladder Neoplasms with a site in Italy, from their registry updates:
Observational study on the quality of life and pathological state of patients underwent radical cystectomy.
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:
Patients with muscle-invasive bladder cancer underwent radycal cystectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Radical Cystectomy
A radical cystectomy is an operation to remove the whole bladder
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.
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
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2013 (actual). Primary completion is estimated for Feb 2063, 600 months after the start.
Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's planned 600 months is above that.
Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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