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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05148728
• Other study ID #: PR(AG)401/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: December 2021
• Source: Vall Hebron Insitut Recerca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Endoscopic fulguration
already included. WE will use Storz monopolar device for fulguration

Locations

Country	Name	City	State
Spain	Fernando Lozano Palacio	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Vall Hebron Insitut Recerca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression rate	Number of patients that progress during the follow up	two years
Primary	Complications rate	Number and grade of complications in both arms. Clavien Dindo Scale will be used	two years
Secondary	recurrence rate	number of recurrences	two years
Secondary	quality of life measured with CAVICAVENMI questionnaire	quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used	two years