An interventional study of MOHS micrographic surgery and Wide local excision in Dermatofibrosarcoma Protuberans, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 1 Year to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Dermatofibrosarcoma; 9 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 36 interventional studies indexed under Dermatofibrosarcoma.
Browse Dermatofibrosarcoma studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Must be 10 years of age or younger. Must have proven dermatofibrosarcoma protuberans.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.
Procedure: MOHS micrographic surgery · Procedure: Wide local excision
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.
A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.
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.
Time frame: Recurrence will be assessed at 1 year.
All cause mortality
Death secondary to any cause
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.
Mortality related to dermatofibrosarcoma protuberans
Death which is directly related to the dermatofibrosarcoma or complications related to it as judged by clinical investigators
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.
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.
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.
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.
Time frame: 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.
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.
Time frame: Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up)
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.