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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001972-41-FI

Enrollment

Registered

2021-05-07

Start date

2021-06-24

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Warthin's tumor

Interventions

Trade Name: Bleomycin Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 - clinical and radiological treatment response 6 and 12 months after bleomycin schlerotherapy;Timepoint(s) of evaluation of this end point: 6 and 12 months	—

Measure

Time frame

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 - 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

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: 12 months yearly up to 5 years	—

Countries

Finland

Contacts

Public ContactKorva-, nenä- ja kurkkutaudit

Helsinki University Hospital, Otorhinolaryngology and Head and Neck Surgery

+358407339084

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026