Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

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.

Study Overview

• Status: Completed
• Conditions: Dermatofibrosarcoma Protuberans
• Intervention / Treatment: Procedure: MOHS micrographic surgery; Procedure: Wide local excision

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MOHS treatment arm; Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.

Procedure: MOHS 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.; Procedure: Wide local excision; A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Randall K Roenigk, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Sarcoma; Neoplasms, Fibrous Tissue; Fibrosarcoma; Dermatofibrosarcoma
• Other Study ID Numbers: 16-010617

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No