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Mohs and Immunofluorescence for Malignant Melanoma In Situ

Primary Purpose

Lentigo Maligna, Melanoma In Situ

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H&E
IHC MART-1
IF MART-1
IF cocktail
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lentigo Maligna focused on measuring Melanoma In Situ, Lentigo Maligna, Confocal Microscopy, Direct Immunofluorescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female of any race and at least 18 years of age
  2. Patient with biopsied proven Lentigo maligna (LM) in situ

  3. Patient meets criteria for Mohs Micrographic Surgery (MMS)

    1. The cancer is large
    2. The edges of the cancer (clinical margins) cannot be clearly defined
    3. Prior treatment has failed, i.e. recurrent tumor
    4. 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)
    5. The histologic pattern of the cancer is aggressive
    6. The patient is immunosuppressed

  4. Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:

    1. 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.
    2. Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
    3. Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
  5. Patient able to tolerate surgery
  6. Patient is able to comply with appointments including follow-up appointments
  7. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients under the age of 18
  2. Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
  3. Patient with previously diagnosed invasive LM
  4. Patients unable to comply with follow-up
  5. Adults unable to consent
  6. Pregnant women
  7. Prisoners

Sites / Locations

  • Sylvester Comprenhensive Cancer Center
  • University of Miami Hospital dermatology clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard vs. IF MART-1

IF MART-1 versus IF cocktail

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2014
Last Updated
January 3, 2019
Sponsor
University of Miami
Collaborators
University of Miami Sylvester Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02306512
Brief Title
Mohs and Immunofluorescence for Malignant Melanoma In Situ
Official Title
Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI is leaving the University of Miami
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
University of Miami Sylvester Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lentigo Maligna, Melanoma In Situ
Keywords
Melanoma In Situ, Lentigo Maligna, Confocal Microscopy, Direct Immunofluorescence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard vs. IF MART-1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IF MART-1 versus IF cocktail
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
H&E
Intervention Description
Sample will be stained with H&E according to standard procedures
Intervention Type
Procedure
Intervention Name(s)
IHC MART-1
Intervention Description
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
Intervention Type
Procedure
Intervention Name(s)
IF MART-1
Intervention Description
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
Intervention Type
Procedure
Intervention Name(s)
IF cocktail
Intervention Description
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.
Primary Outcome Measure Information:
Title
IF MART-1 versus Standard H&E and IHC MART-1
Description
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
Time Frame
End of Mohs Surgery, approximately up to 24 hours
Secondary Outcome Measure Information:
Title
IF cocktail vs IF MART-1 alone
Description
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
Time Frame
End of Mohs Surgery, approximately up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Grichnik, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvester Comprenhensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital dermatology clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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Mohs and Immunofluorescence for Malignant Melanoma In Situ

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