Mohs and Immunofluorescence for Malignant Melanoma In Situ
Status: | Withdrawn |
---|---|
Conditions: | Skin Cancer, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/9/2019 |
Start Date: | June 2015 |
End Date: | November 2015 |
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.
features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs
Micrographic Surgery.
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.
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.
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
We found this trial at
2
sites
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