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

NCT05148728 | Unknown

• 1 other identifier: PR(AG)401/2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

active surveillance; fulguration; bladder cancer

Outcome Measures

Primary Outcomes (2)

• Progression rate

  Number of patients that progress during the follow up

  two years

• Complications rate

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

  two years

Secondary Outcomes (2)

• recurrence rate

  two years

• quality of life measured with CAVICAVENMI questionnaire

  two years

Study Arms (2)

Active surveillance

NO INTERVENTION

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

endoscopic fulguration

ACTIVE COMPARATOR

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

Interventions

Endoscopic fulguration PROCEDURE

already included. WE will use Storz monopolar device for fulguration

Also known as: Active surveillance

endoscopic fulguration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vall Hebron Insitut Recerca: lead

Study Sites (1)

Fernando Lozano Palacio

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 8, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2023
• Study Completion: March 15, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the recruitment (two years), data will be available, for 5 years

Locations

ES (1)