Lentigo MalignaNCT02306512
Mohs and Immunofluorescence for Malignant Melanoma In Situ
A study testing H&E, IHC MART-1 and IF MART-1 in people with Lentigo Maligna and Melanoma In Situ, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lentigo Maligna, Melanoma In Situ
- What is being tested?
- H&E, IHC MART-1 and IF MART-1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race and at least 18 years of age
- Patient with biopsied proven Lentigo maligna (LM) in situ
- Patient meets criteria for Mohs Micrographic Surgery (MMS)
- The cancer is large
- The edges of the cancer (clinical margins) cannot be clearly defined
- Prior treatment has failed, i.e. recurrent tumor
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- The cancer is located in a cosmetically sensitive or functionally critical area of the body (such as eyelids, nose, ears, lips, fingers, toes, and genitals)
- The histologic pattern of the cancer is aggressive
- The patient is immunosuppressed
- Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
- Area H: ''Mask areas'' of face (central face, eyelids [including inner/outer canthi], eyebrows, nose, lips [cutaneous/mucosal/vermillion], chin, ear and periauricular skin/sulci, temple), genitalia (including perineal and perianal), hands, feet, nail units, ankles, and nipples/areola.
- Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
- Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
- Patient able to tolerate surgery
- Patient is able to comply with appointments including follow-up appointments
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Patients under the age of 18
- Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
- Patient with previously diagnosed invasive LM
- Patients unable to comply with follow-up
- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sylvester Comprenhensive Cancer Center
Miami, Florida, 33136
University of Miami Hospital dermatology clinics
Miami, Florida, 33136
About this study
Official title: Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
The purpose of this study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery.
Read the detailed description
The aim of this study is to
- Determine the feasibility of using melanocytic markers such as Melanoma antigen recognized by T cells 1 (MART-1) with fluorescence to clear surgical margins when compared to conventional MART-1 immunohistochemistry (IHC) in the setting of MMS for LM (lentigo maligna type melanoma in situ).
- Compare the use of a cocktail of immunofluorescent markers such as, but not limited to, Sex-determining Region Y (SRY)-box 10 (SOX10), human melanoma black 45 (HMB-45), and Kiel-67 (Ki-67) to sections only stained with fluorescent MART-1 alone.
- Explore the value of using other combinations of immunofluorescent markers such as S-100 with Microphthalmia-associated transcription factor (MiTF), Nestin with Ki-67, and HMB-45 with Lamin.
- Conditions
- Lentigo Maligna, Melanoma In Situ
- Being tested
- H&E, IHC MART-1, IF MART-1, IF cocktail
- Keywords
- Melanoma In Situ, Lentigo Maligna, Confocal Microscopy, Direct Immunofluorescence
- Medical subject headings
- Hutchinson's Melanotic Freckle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H&EProcedure or surgery
Sample will be stained with H\&E according to standard procedures
IHC MART-1Procedure or surgery
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
IF MART-1Procedure or surgery
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
IF cocktailProcedure or surgery
The fluorescent primary antibodies may include HMB-45, SOX10, Ki-67 and MART-1. However other markers will be considered to make the most visually remarkable cocktail; these may include S-100, MiTF, lamin and nestin. Primary antibodies will be tagged with secondary antibodies labeled with fluorescent signals. A fluorescent organelle stain and/or 4',6-diamidine-2-phenylindol (DAPI) may also be used to enhance cellular architecture.
| Study group | Role | What they receive |
|---|---|---|
| Standard vs. IF MART-1 | Active comparator | Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H\&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H\&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before. Receives: Procedure: H&E; Procedure: IHC MART-1; Procedure: IF MART-1 |
| IF MART-1 versus IF cocktail | Active comparator | In the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies. Receives: Procedure: IF MART-1; Procedure: IF cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
IF MART-1 versus Standard H&E and IHC MART-1
Comparison of the number of high power fields containing melanoma in situ with IF Mart-1 vs. standard H\&E and IHC Mart-1 when evaluating margins during MMS
Measured: End of Mohs Surgery, approximately up to 24 hours
Secondary outcomes (1)
IF cocktail vs IF MART-1 alone
Comparison of the number of high-power fields containing melanoma in situ with IF cocktail vs. IF Mart-1 alone when evaluating margins during MMS
Measured: End of Mohs Surgery, approximately up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: PI is leaving the University of Miami
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lentigo MalignaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami Sylvester Comprehensive Cancer Center
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- James Grichnik, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306512
- Sponsor's protocol ID
- 20140210
- Other IDs
- 0000000
- Status last verified
- Jan 2019
- First submitted
- 27 Aug 2014
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
- ClinicalTrials.gov ID
- NCT02306512
- Acronym / sponsor ID
- 20140210
- Conditions
- Lentigo Maligna, Melanoma In Situ
- Keywords
- Melanoma In Situ, Lentigo Maligna, Confocal Microscopy, Direct Immunofluorescence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is leaving the University of Miami
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- University of Miami Sylvester Comprehensive Cancer Center
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Dec 2014 (estimated)
- 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 study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery.
Detailed description
The aim of this study is to
- Determine the feasibility of using melanocytic markers such as Melanoma antigen recognized by T cells 1 (MART-1) with fluorescence to clear surgical margins when compared to conventional MART-1 immunohistochemistry (IHC) in the setting of MMS for LM (lentigo maligna type melanoma in situ).
- Compare the use of a cocktail of immunofluorescent markers such as, but not limited to, Sex-determining Region Y (SRY)-box 10 (SOX10), human melanoma black 45 (HMB-45), and Kiel-67 (Ki-67) to sections only stained with fluorescent MART-1 alone.
- Explore the value of using other combinations of immunofluorescent markers such as S-100 with Microphthalmia-associated transcription factor (MiTF), Nestin with Ki-67, and HMB-45 with Lamin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard vs. IF MART-1 | Active comparator | Procedure: H&E, Procedure: IHC MART-1, Procedure: IF MART-1Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H\&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H\&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before. |
| IF MART-1 versus IF cocktail | Active comparator | Procedure: IF MART-1, Procedure: IF cocktailIn the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female of any race and at least 18 years of age
- Patient with biopsied proven Lentigo maligna (LM) in situ
- Patient meets criteria for Mohs Micrographic Surgery (MMS)
- Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
- Patient able to tolerate surgery
Key exclusion criteria (7 listed)
- Patients under the age of 18
- Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
- Patient with previously diagnosed invasive LM
- Patients unable to comply with follow-up
- Adults unable to consent
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 |
|---|---|---|
| H&ESample will be stained with H\&E according to standard procedures | Procedure or surgery | Standard vs. IF MART-1 |
| IHC MART-1Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures. | Procedure or surgery | Standard vs. IF MART-1 |
| IF MART-1Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures. | Procedure or surgery | IF MART-1 versus IF cocktail, Standard vs. IF MART-1 |
| IF cocktailThe fluorescent primary antibodies may include HMB-45, SOX10, Ki-67 and MART-1. However other markers will be considered to make the most visually remarkable cocktail; these may include S-100, MiTF, lamin and nestin. Primary antibodies will be tagged with secondary antibodies labeled with fluorescent signals. A fluorescent organelle stain and/or 4',6-diamidine-2-phenylindol (DAPI) may also be used to enhance cellular architecture. | Procedure or surgery | IF MART-1 versus IF cocktail |
Primary outcome
IF MART-1 versus Standard H&E and IHC MART-1
Time frame: End of Mohs Surgery, approximately up to 24 hours
Comparison of the number of high power fields containing melanoma in situ with IF Mart-1 vs. standard H\&E and IHC Mart-1 when evaluating margins during MMS
1 secondary outcome
IF cocktail vs IF MART-1 alone
Time frame: End of Mohs Surgery, approximately up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
Related trials for Lentigo Maligna
Active, not recruitingPhase 2
Dinaciclib in Treating Patients With Stage IV Melanoma
Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma
Active, not recruitingObservational study
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs
Skin Cancer, Complication
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.
James Grichnik, MD, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H&E, IHC MART-1 and IF MART-1 in people with Lentigo Maligna and Melanoma In Situ, run by University of Miami at 2 sites 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?
The sponsor lists 16 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
IF MART-1 versus Standard H&E and IHC MART-1 (time frame: End of Mohs Surgery, approximately up to 24 hours). 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 7 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.