Mohs and Immunofluorescence for Malignant Melanoma In Situ

Withdrawn before enrolling · Not applicable

Conditions studied: Lentigo Maligna, Melanoma In Situ

In brief

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.

Key facts

Study ID

NCT02306512

Run by

University of Miami

People needed

0

Starts

2015-06-01

Expected to finish

2015-11-01

Last updated by the study team

2019-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sylvester Comprenhensive Cancer Center — Miami, Florida, United States
• University of Miami Hospital dermatology clinics — Miami, Florida, United States

Full record on ClinicalTrials.gov

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