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

Primary Purpose

Bladder Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Endoscopic fulguration
Sponsored by
Vall Hebron Insitut Recerca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring active surveillance, fulguration, bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fernando Lozano Palacio

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Active surveillance

endoscopic fulguration

Arm Description

After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery

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

Outcomes

Primary Outcome Measures

Progression rate
Number of patients that progress during the follow up
Complications rate
Number and grade of complications in both arms. Clavien Dindo Scale will be used

Secondary Outcome Measures

recurrence rate
number of recurrences
quality of life measured with CAVICAVENMI questionnaire
quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used

Full Information

First Posted
November 26, 2021
Last Updated
December 7, 2021
Sponsor
Vall Hebron Insitut Recerca
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1. Study Identification

Unique Protocol Identification Number
NCT05148728
Brief Title
Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors
Official Title
Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2021 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vall Hebron Insitut Recerca

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
active surveillance, fulguration, bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active surveillance
Arm Type
No Intervention
Arm Description
After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery
Arm Title
endoscopic fulguration
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Endoscopic fulguration
Other Intervention Name(s)
Active surveillance
Intervention Description
already included. WE will use Storz monopolar device for fulguration
Primary Outcome Measure Information:
Title
Progression rate
Description
Number of patients that progress during the follow up
Time Frame
two years
Title
Complications rate
Description
Number and grade of complications in both arms. Clavien Dindo Scale will be used
Time Frame
two years
Secondary Outcome Measure Information:
Title
recurrence rate
Description
number of recurrences
Time Frame
two years
Title
quality of life measured with CAVICAVENMI questionnaire
Description
quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fernando Lozano Palacio
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando FL Lozano, MD
Phone
+34636244960
Email
flozano@vhebron.net

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
codified information (anonymous information)
IPD Sharing Time Frame
after completing the recruitment (two years), data will be available, for 5 years

Learn more about this trial

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

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