Treatment of Warthin's tumor: schlerotherapy and its natural course

Phase 1

• Conditions: Warthin's tumor; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2021-001972-41-FI
• Lead Sponsor: Helsinki University Hospital, Otorhinolaryngology and Head and Neck Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-07
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- the tumor is clinically, cytologically and radiologically confirmed as Warthin's tumor. The cytology is confirmed by HUSLAB's head and neck pathologist.
- the patient is eligible for MRI examination
- age 18 or older
- the tumor locates in the parotid gland
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- the patient prefers surgical treatment or follow-up
- fibrotic lung disease
- chronic kidney injury (GFR < 50ml/min)
- the patient does not understand the study information document (in Finnish and Swedish)
- cancer under active treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A pilot study on schlerotherapy with Bleomycin for Warthin's tumor for patients non-eligible or not willing for first-line operative treatment;Secondary Objective: To investigate the natural course of Warthin's tumor on those patients not wanting any therapy.;Primary end point(s): Primary end point<br>- clinical and radiological treatment response 6 and 12 months after bleomycin schlerotherapy;Timepoint(s) of evaluation of this end point: 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - follow-up patient group: clinical and radiological status 12 months after diagnosis, clinical symptom score up to 5 years from diagnosis<br>;Timepoint(s) of evaluation of this end point: 12 months<br>yearly up to 5 years