Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Dermatofibrosarcoma Protuberans Clinical Trial

Official title:

Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381846
• Other study ID #: 16-010617
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatofibrosarcoma
• Dermatofibrosarcoma Protuberans

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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)

External Links

•   Mayo Clinic Clinical Trials