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Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

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ClinicalTrials.gov Identifier: NCT03381846
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Randall K. Roenigk, 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.

Condition or disease Intervention/treatment Phase
Dermatofibrosarcoma Protuberans Procedure: MOHS micrographic surgery Procedure: Wide local excision Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381846


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kevin R Brough, MD    507-284-0066    brough.kevin@mayo.edu   
Contact: Molly J Youssef, MD    507-284-3837    Youssef.Molly@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Randall K Roenigk Mayo Clinic

Responsible Party: Randall K. Roenigk, Professor of Dermatology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03381846     History of Changes
Other Study ID Numbers: 16-010617
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatofibrosarcoma
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma