Skip to main content
OpenTrials
Completed

NCT Number: NCT03381846

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatofibrosarcoma Protuberans Dermatofibrosarcoma Fibrosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Sarcoma

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mohs micrographic surgery

Procedure

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

Procedure

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

Primary outcomes

  1. Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year.

    Time frame: 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 outcomes

  1. All cause mortality

    Time frame: 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

  2. Mortality related to dermatofibrosarcoma protuberans

    Time frame: 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

  3. Morbidity secondary to surgical procedure

    Time frame: 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.

  4. Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at two years.

    Time frame: 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.

  5. Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at five years.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2017
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.