E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Basal cell carcinomas |
Basalcellekarcinomer |
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E.1.1.1 | Medical condition in easily understood language |
Skin cancer |
Almindelig hudkræft |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042503 |
E.1.2 | Term | Superficial basal cell carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073093 |
E.1.2 | Term | Nodular basal cell carcinoma |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
Efficacy of calcium electroporation in the treatment of primary low risk basal cell carcinomas |
Formålet med forsøget er undersøge behandlingseffekten af calcium elektroporation til behandling af primære lavrisiko basalcellekarcinomer < 3 cm i diameter. |
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E.2.2 | Secondary objectives of the trial |
Side effects after treatment (erythema, pain, oedema and ulceration) 1 year recurrence rate Cosmetic outcome 3 and 12 months after treatment |
• Vurdering af bivirkninger ved CaEP af basalcellekarcinomer såsom smerter, rødme, hævelse og sårdannelse • 1 års recidivraten efter CaEP af BCC • Kosmetisk resultat 3 og 12 måneder efter behandlingen vurderet af patienten og speciallæge i dermatologi
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients > 18 years of age Biopsi proven primary low risk basal cell carcinom less than 3 cm in diameter Oral and written consent before inclusion |
• Forsøgsperson > 18 år • Biopsiverificeret primært lavrisiko basalcellekarcinom < 3 cm i diameter • Informeret mundtligt samtykke og underskreven skriftligt samtykke før inklusion
|
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E.4 | Principal exclusion criteria |
Basal cell carcinomas on the tip of the nose, eye lids, ears, lips and scalp Recurrent lesions Organ transplantation or immunosuppression Pregnant or breast feeding Allergy to local anesthetics |
• Basalcellekarcinomer lokaliseret på næsetip, øjenlåg, ører, læber eller hårbund • Recidiver efter tidligere behandling • Organtransplanterede eller immunsupprimerede patienter • Gravide eller ammende • Patienter som er allergiske overfor lokalbedøvelse
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical tumor response by dermatologist and OCT guided biopsy |
• Klinisk tumorrespons vurderet af speciallæge i dermatologi • Tumorrespons vurderet med OCT vejledt biopsi
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months after last treatment |
3 måneder efter sidste behandling |
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E.5.2 | Secondary end point(s) |
Side effects after treatment 1 year recurrence rate Cosmetic outcome |
• Vurdering af bivirkninger ved CaEP af basalcellekarcinomer såsom smerter, rødme, hævelse og sårdannelse • 1 års recidivraten efter CaEP af BCC • Kosmetisk resultat vurderet af patienten og speciallæge i dermatologi
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Side effects: 2-12 weeks, 3 and 12 months Recurrence rate: 1 year Cosmetic outcome: 3 and 12 months |
Bivirkninger: 2-12 uger, 3 måneder og 12 måneder Recidivrate: 12 måneder Kosmetisk resultat: 3 og 12 måneder |
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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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
The last visit of the last subject undergoing the trial |
Sidste besøg af den sidste forsøgsperson der indgår i forsøget |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |