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

December 11, 2023 updated by: Francesco Montorsi, IRCCS San Raffaele

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).

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obtain health benefit for the patients themselves and for future patients suffering from bladder cancer
Time Frame: 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.
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.
improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Francesco Montorsi, MD, IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2013

Primary Completion (Estimated)

November 27, 2063

Study Completion (Estimated)

November 27, 2063

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. 2007-Vescica

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe