Clinical trial · Interventional
Mohs and Immunofluorescence for Malignant Melanoma In Situ
Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
NCT02306512CI-TRIAL-00036367withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI is leaving the University of Miami
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lentigo Maligna | Lentigo Maligna | ONTOLOGY_EXACT | 0.98 |
| Melanoma In Situ | Melanoma In Situ | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| H&E | Procedure | — | UNRESOLVED |
| IF cocktail | Procedure | — | UNRESOLVED |
| IF MART-1 | Procedure | — | UNRESOLVED |
| IHC MART-1 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard vs. IF MART-1
- 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.
- interventionNames
- Procedure: H&E
- Procedure: IHC MART-1
- Procedure: IF MART-1
- type
- ACTIVE_COMPARATOR
- label
- IF MART-1 versus IF cocktail
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.