Clinical trial NCT02306512: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Lentigo Maligna
Melanoma In Situ
Keywords: Melanoma In Situ
Lentigo Maligna
Confocal Microscopy
Direct Immunofluorescence
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: University of Miami Sylvester Comprehensive Cancer Center
First posted: 2014-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

1. 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).
2. 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.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: IF MART-1 versus Standard H&E and IHC MART-1
timeFrame: End of Mohs Surgery, approximately up to 24 hours
Secondary outcomes:
measure: IF cocktail vs IF MART-1 alone
timeFrame: End of Mohs Surgery, approximately up to 24 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprenhensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital dermatology clinics
state: Florida
Study officials:
affiliation: University of Miami
name: James Grichnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: