Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Not Applicable

Completed

• Conditions: Dermatofibrosarcoma Protuberans
• Interventions: Procedure: MOHS micrographic surgery; Procedure: Wide local excision

• Registration Number: NCT03381846
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-22
• Study Start: 2018-07-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOHS treatment arm	Wide local excision	Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.
MOHS treatment arm	MOHS micrographic surgery	Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States