Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

Not Applicable

• Conditions: Basal Cell Carcinoma (BCC)
• Interventions: Procedure: Intralesional cryotherapy

• Registration Number: NCT01633515
• Lead Sponsor: Carmel Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-06-09
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-01
• Study First Posted: 2012-07-04
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03
• Primary Completion: 2014-04
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intralesional cryotherapy	Intralesional cryotherapy	10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications.

Primary Outcome Measures

Name	Time	Method
Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly	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).	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

Trial Locations

Locations (1)

Lin Medical Center; 🇮🇱 Haifa, Israel