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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05148728
Recruitment Status : Unknown
Verified December 2021 by Vall Hebron Insitut Recerca.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2021
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Vall Hebron Insitut Recerca

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Endoscopic fulguration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : March 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Active surveillance


Outcome Measures
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Primary Outcome Measures :
  1. Progression rate [ Time Frame: two years ]
    Number of patients that progress during the follow up

  2. Complications rate [ Time Frame: two years ]
    Number and grade of complications in both arms. Clavien Dindo Scale will be used


Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: two years ]
    number of recurrences

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05148728


Locations
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Spain
Fernando Lozano Palacio
Barcelona, Spain, 08035
Contact: Fernando FL Lozano, MD    +34636244960    flozano@vhebron.net   
Sponsors and Collaborators
Vall Hebron Insitut Recerca
More Information
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Responsible Party: Vall Hebron Insitut Recerca
ClinicalTrials.gov Identifier: NCT05148728    
Other Study ID Numbers: PR(AG)401/2021
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: codified information (anonymous information)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: after completing the recruitment (two years), data will be available, for 5 years

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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
Keywords provided by Vall Hebron Insitut Recerca:
active surveillance
fulguration
bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases