NCT03381846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

November 9, 2017

Last Update Submit

August 4, 2020

Conditions

Dermatofibrosarcoma Protuberans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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)

  • 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)

Study Arms (1)

MOHS treatment arm

EXPERIMENTAL

Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.

Procedure: MOHS micrographic surgeryProcedure: Wide local excision

Interventions

MOHS micrographic surgeryPROCEDURE

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.

MOHS treatment arm
Wide local excisionPROCEDURE

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

MOHS treatment arm

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Dermatofibrosarcoma

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

FibrosarcomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

MicrosurgerySurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery Procedures

Study Officials

  • Randall K Roenigk

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dermatology

Study Record Dates

First Submitted

November 9, 2017

First Posted

December 22, 2017

Study Start

July 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

US(1)