E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Warthin's tumor |
Warthinin tuumori |
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E.1.1.1 | Medical condition in easily understood language |
Warthin's tumor |
Warthinin tuumori |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
A pilot study on schlerotherapy with Bleomycin for Warthin's tumor for patients non-eligible or not willing for first-line operative treatment |
Pilottitutkimus bleomysiiniskleroterapian soveltuvuudesta Warthinin tuumorin hoidossa potilialle, jotka eivät sovellu tai eivät halua ensilinjan leikkaushoitoa |
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E.2.2 | Secondary objectives of the trial |
To investigate the natural course of Warthin's tumor on those patients not wanting any therapy. |
Tutkia Warthinin tuumorin luonnollista kulkua niillä potilailla, jotka eivät halua mitään hoitoa tuumoriin. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
1. Edellytykset sille, että potilaalle tarjotaan skleroterapiahoitoa eli inkluusiokriteerit: - Kasvaimen tulee kliinisesti, radiologisesti ja sytologisesti sopia Warthinin tuumoriksi. Sytologian tulee perustua HUSLAB:n pään ja kaulan kasvaimiin perehtyneen patologin arvioon. Muualla otetusta sytologisista näytteistä pyydetään uudelleenarvio. - Potilaalle on mahdollista tehdä magneettikuvaus - ≥ 18 vuoden ikä - Kasvain on korvasylkirauhasessa. Syynä rajaukseen on se, että muissa lokalisaatioissa kyseinen tuumori on harvinainen ja siten jäisi merkittävämpi virhemahdollisuus väärälle diagnoosille.
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E.4 | Principal 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 |
Ekskluusiokriteerit: - Potilas toivoo ensisijaisesti leikkaushoitoa tai pelkkää seurantaa - Tiedossa oleva fibrotisoiva keuhkosairaus - Tiedossa oleva munuaisten vajaatoiminta (kreatiniinipuhdistuma (GFR) on < 50 ml/min) - Potilas ei ymmärrä tutkimusselostetta, joka on olemassa sekä suomeksi että ruotsiksi - Aktiivihoidossa oleva syöpäsairaus
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point - clinical and radiological treatment response 6 and 12 months after bleomycin schlerotherapy |
Ensisijainen end point - kliininen ja radiologine hoitovaste 6 ja 12 kk bleomysiiniskelroterapiahoidosta |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 ja 12 kk |
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E.5.2 | 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
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- seurantalinjan potilaiden kliininen ja radiologien tilanne 12kk taudin toteamisesta, seurantalinjan potilaiden oirekysely ad 5 v. diagnoosista
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 months yearly up to 5 years |
12 kk vuosittain ad 5 vuotta |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study continues until 20-30 patients have been recruited for bleomycin schlerotherapy |
Tutkimusta jatketaan kunnes bleomysiiniskleroterapiaryhmään on saatu mukaan 20-30 potilasta |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |