Mohs and Immunofluorescence for Malignant Melanoma In Situ

Lentigo Maligna Clinical Trial

Official title:

Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02306512
• Other study ID #: 20140210
• Secondary ID: 0000000
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lentigo
• Lentigo Maligna
• Melanoma
• Melanoma In Situ

Intervention

Procedure:
• H&E
Sample will be stained with H&E according to standard procedures
• IHC MART-1
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
• IF MART-1
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
• IF cocktail
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.

Locations

Country	Name	City	State
United States	Sylvester Comprenhensive Cancer Center	Miami	Florida
United States	University of Miami Hospital dermatology clinics	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End of Mohs Surgery, approximately up to 24 hours
Secondary	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	End of Mohs Surgery, approximately up to 24 hours