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| Name | Class |
|---|---|
| HUS Skin and Allergy Hospital | OTHER |
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This prospective, randomized, controlled, and single-blinded non-inferiority clinical trial compare the efficacy and tolerability of high intensity focused ultrasound (HIFU) to standard cryotherapy in the treatment of low-risk basal cell carcinomas (BCCs) and Bowen's disease (BD) in adults. The main questions it aims to answer are:
Researchers will compare HIFU to standard cryotherapy with liquid nitrogen to see if the ultrasound works to treat these local and low-risk non-melanosytic skin cancers.
Participants will:
Low-risk BCCs and BD are both local keratinocyctic skin cancers with increasing prevalence and they cause a rising burden to the health care system. In this study we assess the efficacy of HIFU compared to liquid nitrogen cryotherapy between years 2025-2030.
Alltogether 294 patients are recruited based on referrals or from patients attending the clinic, with histologically confirmed BD, superficial BCC or nodular BCC located between neck and knees. 98 tumors of each aforementioned subtypes will be recruited and randomized with 1:1 ratio to HIFU and CRYO - groups. Follow-up appointments are 4 weeks, 1-, 3- and 5 years post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sBCC | Experimental | Superficial basal cell carcinoma |
|
| nBCC | Experimental | Nodular basal cell carcinoma |
|
| BD | Experimental | Bowen's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Focused Ultrasound | Device | High intensity focused ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy | Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no. | From treatment to the end of follow up at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during treatment assessed by NRS | Zero is equivalent to no pain and 10 indicates the worst possible pain | Pain during treatment procedure on treatment visit |
| Pain after treatment previous 4 weeks NRS |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment costs | Time and resources required on treatment, cost effectiveness analysis | From treatment to the control at 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Investigator | Contact | +358401986550 | jussi.salonen@hus.fi | |
| Clinical Investigator | Contact | +358504287980 | mari.salmivuori@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Sari Koskenmies, Head of Department | Helsinki University Hospital, Skin and Allergy Hospital, Dermatologic procedure unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS Iho- ja allergiasairaala | Helsinki | 00250 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | The Finnish Cancer Registry; Syöpätilastosovellus. Vuosiraportti 2023. [Internet]. [cited 2025 Nov 19]. Available from: https://syoparekisteri.fi/tilastot/tautitilastot/ | ||
| 35551965 | Background | Schlessinger DI, Reynolds KA, Dirr MA, Ibrahim SA, Yanes AF, Lazaroff JM, Godinez-Puig V, Chen BR, Kurta AO, Cotseones JK, Chiren SG, Furlan KC, Iyengar S, Behshad R, DeHoratius DM, Denes P, Drucker AM, Dzubow LM, Etzkorn JR, Harwood CA, Kim JYS, Lawrence N, Lee EH, Lissner GS, Marghoob AA, Matin RN, Mattox AR, Mittal BB, Thomas JR, Zhou XA, Zloty D, Schmitt J, Kirkham JJ, Armstrong AW, Basset-Seguin N, Billingsley EM, Bordeaux JS, Brewer J, Brown M, Brown M, Collins SAB, Fargnoli MC, De Azevedo SJ, Dummer R, Eggermont A, Goldman GD, Haedersdal M, Hale EK, Hanlon A, Harms KL, Huang CC, Hurst EA, In GK, Kelleners-Smeets N, Kheterpal M, Leshin B, Mcdonald M, Miller SJ, Miller A, Mostow EN, Trakatelli M, Nehal KS, Ratner D, Rogers H, Sarin KY, Soon SL, Stasko T, Storrs PA, Tagliaferri L, Vidimos AT, Wong SL, Yu SS, Zalaudek I, Zeitouni NC, Zitelli JA, Poon E, Sobanko JF, Cartee TV, Maher IA, Alam M. Development of a core outcome set for basal cell carcinoma. J Am Acad Dermatol. 2022 Sep;87(3):573-581. doi: 10.1016/j.jaad.2022.04.059. Epub 2022 May 10. |
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The informed consent obtained from participants does not include permission for sharing individual-level data with external researchers. Also, data sharing is restricted due to institutional and contractual agreements that do not permit external distribution of individual-level data.
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| Cryotherapy | Procedure | Liquid nitrogen cryotherapy |
|
|
Zero is equivalent to no pain and 10 indicates the worst possible pain
| From treatment to the control visit at 4 weeks |
| Post treatment reactions assessed by both observer and patient | Yes/no: crust, ulceration, erosion, erythema, oozing, infection | From treatment to the control visit at 4 weeks |
| Healing result assessed by both observer and patient | Healed (defined as no ulcer/crust left)? Yes/no | From treatment to the control visit at 4 weeks |
| Healing time assessed by patient. How many weeks ago? | If defined as healed by the patient. | From treatment to the control visit at 4 weeks |
| Cosmetic outcome assessed by both observer and the patient | Poor/fair/goof/excellent | From 1 year control to the end of follow up at 5 years |
| Patient satisfaction inquiry, modified 6 questions | Patients will be asked about an overall satisfaction with the provided treatment, recommendation of the received treatment to other patients, readiness to undergo the same treatment again and post-treatment recovery and its impact on daily life. Answers will be evaluated with a modified NRS-scale from 0 to 10 | From 1 year control to the end of follow up at 5 years |
| Scarring after treatment POSAS 2.0 | Patient and Observer Scar Assessment Scale (POSAS 2.0) | From 1 year control to the end of follow up at 5 years |
| Other adverse events related to the given treatment | Separate inquiry of adverse events | From treatment visit to the end of follow up at 5 years |
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| Background | WHO, Lucas Robyn, Prüss-Üstün Annette. Solar ultraviolet radiation : global burden of disease from solar ultraviolet radiation. World Health Organization, Public Health and the Environment; 2006. |
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| ID | Term |
|---|---|
| D001913 | Bowen's Disease |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D018295 | Neoplasms, Basal Cell |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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