Clinical trial NCT06167356: Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
Official title: 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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
Non-Muscle Invasive Bladder Urothelial Carcinoma
Bladder Cancer
Bladder Disease
Bladder Neoplasm
Bladder Urothelial Carcinoma
Bladder Cancer Stage I, With Cancer in Situ
Bladder Cancer Recurrent
Bladder Urothelial Carcinoma in Situ
Bladder Urothelial Dysplasia
Keywords: Intravescical Therapies
Bladder Urothelial Carcinoma
Bladder Neoplasm
Bladder Disease
Bladder Cancer
Intravesical Instillations
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non muscle-invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES

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.

Eligibility criteria: 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

Primary outcomes:
measure: obtain health benefit for the patients themselves and for future patients suffering from bladder cancer
timeFrame: 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.
measure: improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Francesco Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References: