Dermatofibrosarcoma Protuberans
Conditions
Brief summary
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.
Interventions
PROCEDUREMOHS micrographic surgery
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.
PROCEDUREWide local excision
A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year. | Recurrence will be assessed at 1 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 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. | Death secondary to any cause |
| Mortality related to dermatofibrosarcoma protuberans | 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. | Death which is directly related to the dermatofibrosarcoma or complications related to it as judged by clinical investigators |
| Morbidity secondary to surgical procedure | 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. | 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. |
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at two years. | Recurrence will be assessed at 2 years. (Not all patients will have a full two years of follow up) | 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. |
| Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at five years. | Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up) | 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. |
Countries
United States
Outcome results
None listed