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

S

San Donato Group (GSD)

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT06167356
Prot. 2007-Vescica

Details and patient eligibility

About

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.

Full 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.

Enrollment

20,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20,000 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Giusy Burgio, MSc; Francesco Montorsi, MD

Data sourced from clinicaltrials.gov

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