Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

Study Overview
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Brief Summary
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A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery. 10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment

Detailed Description
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BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy. surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice. 10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.

Official Title
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Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study

Conditions
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Basal Cell Carcinoma (BCC)

Intervention / Treatment
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* Procedure: Intralesional cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 60 years old BCC was determined with tissue diagnosis in the lower extremity One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use. Exclusion Criteria: Patient unable to read, understand and sign the consent form

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intralesional cryotherapy<br>10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications. | Procedure: Intralesional cryotherapy<br>* The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn. Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).<br>* Other names: CryoShape; CryoShape™, FDA 510(k) Number K060928);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly | Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate | Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basal cell carcinoma (BCC), Cryotherapy, Cryosurgery