Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Study Overview
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Brief Summary
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The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to explore the challenges that providers face which may prevent them performing this potentially superior treatment. This study will provide a comparison of outcomes and recurrence rates in pediatric patients treated by MOHS versus traditional excision.

Official Title
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Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Conditions
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Dermatofibrosarcoma Protuberans

Intervention / Treatment
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* Procedure: MOHS micrographic surgery
* Procedure: Wide local excision


Participation Criteria
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Eligibility Criteria
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Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: MOHS treatment arm<br>Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery. | Procedure: MOHS micrographic surgery<br>* Mohs surgery is a precise surgical technique used to treat skin cancer. Thin layers of cancer-containing skin are progressively removed and examined microscopically until only cancer-free tissue remains.<br>Procedure: Wide local excision<br>* A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year. | Developing an additional dermatofibrosarcoma protuberans at any location, but particularly noting local recurrence (defined as being within or contiguous to the field of the previous excision. | Recurrence will be assessed at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Death secondary to any cause | All cause mortality will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up. | 
| Mortality related to dermatofibrosarcoma protuberans | Death which is directly related to the dermatofibrosarcoma or complications related to it as judged by clinical investigators | Mortality related to dermatofibrosarcoma protuberans will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up. | 
| Morbidity secondary to surgical procedure | Will be measured by the area of tissue removed and any functional or physical impairment which resulted from the surgical procedure such as limited range of motion, resulting reported pain, or any reported complications. | Morbidity secondary to surgical procedure will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up. | 
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at two years. | Developing an additional dermatofibrosarcoma protuberans at any location, but particularly noting local recurrence (defined as being within or contiguous to the field of the previous excision. | Recurrence will be assessed at 2 years. (Not all patients will have a full two years of follow up) | 
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at five years. | Developing an additional dermatofibrosarcoma protuberans at any location, but particularly noting local recurrence (defined as being within or contiguous to the field of the previous excision. | Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up) |