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

Sponsor
Vall Hebron Insitut Recerca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05148728
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic fulguration
 N/A

Study Design

Study Type:
Interventional
Anticipated 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.
Anticipated Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Mar 15, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression rate [two years]

      Number of patients that progress during the follow up

    2. Complications rate [two years]

      Number and grade of complications in both arms. Clavien Dindo Scale will be used

    Secondary Outcome Measures

    1. recurrence rate [two years]

      number of recurrences

    2. quality of life measured with CAVICAVENMI questionnaire [two years]

      quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fernando Lozano Palacio Barcelona Spain 08035

    Sponsors and Collaborators

    • Vall Hebron Insitut Recerca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vall Hebron Insitut Recerca
    ClinicalTrials.gov Identifier:
    NCT05148728
    Other Study ID Numbers:
    • PR(AG)401/2021
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Dec 8, 2021