Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors

December 7, 2021 updated by: Vall Hebron Insitut Recerca

Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.

Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.

Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.

This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.

This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Fernando Lozano Palacio
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
  • Accept cystoscopy surveillance
  • Main lession less than 10mm
  • Less than 7 lesions
  • Negative or low grade cytology
  • No solid aspect

Exclusion Criteria:

  • previous High grade bladder cancer tumors
  • previous Cis
  • previous Upper Urinary Tract tumor
  • previous pelvic radiotherapy
  • hematuria
  • meatal localisation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Active surveillance
After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery
Active Comparator: endoscopic fulguration
After a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode
Procedure: Endoscopic fulguration
already included. WE will use Storz monopolar device for fulguration
Other Names:
  • Active surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression rate
Time Frame: two years
Number of patients that progress during the follow up
two years
Complications rate
Time Frame: two years
Number and grade of complications in both arms. Clavien Dindo Scale will be used
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: two years
number of recurrences
two years
quality of life measured with CAVICAVENMI questionnaire
Time Frame: two years
quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used
two years

Collaborators and Investigators

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

Sponsor

Vall Hebron Insitut Recerca

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 (Anticipated)

December 15, 2021

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

March 15, 2024

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)401/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

codified information (anonymous information)

IPD Sharing Time Frame

after completing the recruitment (two years), data will be available, for 5 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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