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

Bladder Cancer Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167356
• Other study ID #: Prot. 2007-Vescica
• Status: Recruiting
• Start date: November 27, 2013
• Est. completion date: November 27, 2063

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Francesco Montorsi, MD
• Phone: +390226437286
• Email: montorsi.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: November 27, 2063
• Est. primary completion date: November 27, 2063
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Cancer Recurrent
• Bladder Disease
• Bladder Neoplasm
• Bladder Urothelial Carcinoma
• Bladder Urothelial Carcinoma in Situ
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Transitional Cell
• Neoplasms
• Non Muscle Invasive Bladder Cancer
• Non-Muscle Invasive Bladder Urothelial Carcinoma
• Urinary Bladder Diseases
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Primary	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.	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.