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

NCT ID: NCT06167356

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-27

Study Completion Date

2063-11-27

Brief Summary

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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

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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.

Conditions

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with non-muscle invasive bladder cancer

Patients with non-muscle invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Francesco Montorsi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Montorsi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

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IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Montorsi, MD

Role: CONTACT

Phone: +390226437286

Email: [email protected]

Giusy Burgio, MSc

Role: CONTACT

Phone: +390226436764

Email: [email protected]

Facility Contacts

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Francesco Montorsi, MD

Role: primary

Giusy Burgio, MSc

Role: backup

Other Identifiers

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Prot. 2007-Vescica

Identifier Type: -

Identifier Source: org_study_id