An observational study in Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Neoplasms and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by IRCCS San Raffaele · Observational
A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.
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 follwing the most strict GCPs and privacy norms.
The data entered will concern:
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 300 across 49 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with non muscle-invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES
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.
Patients with non-muscle invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES
obtain health benefit for the patients themselves and for future patients suffering from bladder cancer
All patients, before underwent endoscopic resection surgery, 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: 1 Annual follow-up from the date of surgery until the date in which 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: 1 Annual follow-up from the date of surgery untile the date in which 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 Nov 2013 (actual). Primary completion is estimated for Nov 2063, 600 months after the start.
Of 29 observational studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30. This study's planned 600 months is above that.
How these figures are worked out, and which studies are left out of them.
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