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


N/A
60 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma (BCC)

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly

Outcome Description:

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

Outcome Time Frame:

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).

Safety Issue:

No

Principal Investigator

Yaron Har-Shai, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carmel Medical Center

Authority:

Israel: Ethics Commission

Study ID:

CMC-12-0032-CTIL

NCT ID:

NCT01633515

Start Date:

July 2012

Completion Date:

September 2013

Related Keywords:

  • Basal Cell Carcinoma (BCC)
  • Basal cell carcinoma (BCC)
  • Cryotherapy
  • Cryosurgery
  • Carcinoma
  • Carcinoma, Basal Cell

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