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Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.

Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Endoscopic Resection Surgery for Bladder Cancer (TURBK).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06167356
Enrollment
20000
Registered
2023-12-12
Start date
2013-11-27
Completion date
2063-11-27
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Bladder Cancer Recurrent, Bladder Cancer Stage I, With Cancer in Situ, Bladder Disease, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Urothelial Carcinoma in Situ, Bladder Urothelial Dysplasia, Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma

Keywords

Intravescical Therapies, Bladder Urothelial Carcinoma, Bladder Neoplasm, Bladder Disease, Bladder Cancer, Intravesical Instillations

Brief summary

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.

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 follwing 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

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * Patients with non-muscle invasive bladder cancer * Indication to cancer removal through endoscopic resection surgery * Ability to read and sign the informed consent

Exclusion criteria

* Age \<18 years * Inability to read and sign the informed consent

Design outcomes

Primary

MeasureTime frameDescription
obtain health benefit for the patients themselves and for future patients suffering from bladder cancer1 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.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
improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient1 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.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.

Countries

Italy

Contacts

Primary ContactFrancesco Montorsi, MD
montorsi.francesco@hsr.it+390226437286
Backup ContactGiusy Burgio, MSc
burgio.giusy@hsr.it+390226436764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026