NCT02306512

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

August 27, 2014

Last Update Submit

January 3, 2019

Conditions

Lentigo MalignaMelanoma In Situ

Keywords

Melanoma In SituLentigo MalignaConfocal MicroscopyDirect Immunofluorescence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • IF cocktail vs IF MART-1 alone

    End of Mohs Surgery, approximately up to 24 hours

Study Arms (2)

Standard vs. IF MART-1

ACTIVE COMPARATOR

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.

Procedure: H&EProcedure: IHC MART-1Procedure: IF MART-1

IF MART-1 versus IF cocktail

ACTIVE COMPARATOR

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.

Procedure: IF MART-1Procedure: IF cocktail

Interventions

H&EPROCEDURE

Sample will be stained with H\&E according to standard procedures

Standard vs. IF MART-1
IHC MART-1PROCEDURE

Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.

Standard vs. IF MART-1
IF MART-1PROCEDURE

Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.

IF MART-1 versus IF cocktailStandard vs. IF MART-1
IF cocktailPROCEDURE

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.

IF MART-1 versus IF cocktail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +1 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sylvester Comprenhensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Miami Hospital dermatology clinics

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and Melanomas

Study Officials

  • James Grichnik, MD, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Vice Chairman Department of Dermatology & Cutaneous Surgery

Study Record Dates

First Submitted

August 27, 2014

First Posted

December 3, 2014

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations

US(2)