Dermatofibrosarcoma ProtuberansNCT03381846
Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
A study testing MOHS micrographic surgery and Wide local excision in people with Dermatofibrosarcoma Protuberans, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatofibrosarcoma Protuberans
- What is being tested?
- MOHS micrographic surgery and Wide local excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Dermatofibrosarcoma Protuberans
- Being tested
- MOHS micrographic surgery, Wide local excision
- Medical subject headings
- Dermatofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOHS micrographic surgeryProcedure or 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 excisionProcedure or surgery
A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.
| Study group | Role | What they receive |
|---|---|---|
| MOHS treatment arm | Experimental | Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery. Receives: Procedure: MOHS micrographic surgery; Procedure: Wide local excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recurrence will be assessed at 1 year.
Secondary outcomes (5)
All cause mortality
Death secondary to any cause
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatofibrosarcoma ProtuberansStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall K. Roenigk, Mayo Clinic
- Investigators
- Randall K Roenigk, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381846
- Sponsor's protocol ID
- 16-010617
- Status last verified
- Aug 2020
- First submitted
- 9 Nov 2017
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
- ClinicalTrials.gov ID
- NCT03381846
- Acronym / sponsor ID
- 16-010617
- Conditions
- Dermatofibrosarcoma Protuberans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOHS treatment arm | Experimental | Procedure: MOHS micrographic surgery, Procedure: Wide local excisionPatients who have their dermatofibrosarcoma protuberans excised with MOHS surgery. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOHS micrographic surgeryMohs 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 or surgery | MOHS treatment arm |
| Wide local excisionA surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue. | Procedure or surgery | MOHS treatment arm |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall K Roenigk principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOHS micrographic surgery and Wide local excision in people with Dermatofibrosarcoma Protuberans, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year. (time frame: Recurrence will be assessed at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.