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Open (Enrolling)
Both
Melanoma

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Trial Information


The primary objective of this study to test the hypothesis that, among eligible and
evaluable lesions with central histological reference standard status melanoma or high-grade
lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use
with enrolling dermatologists if MelaFind were not available is greater than 110%. This
represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and
effectiveness of MelaFind in a clinical setting.


Inclusion Criteria:



- The lesion is pigmented (i.e., melanin, keratin, blood)

- Clinical management of the lesion by the examining dermatologist is either biopsy of
the lesion in toto, or 3-month follow-up of the lesion

- The diameter of the pigmented area is between 2 and 22 millimeters

- The lesion is accessible to the MelaFind hand-held imaging device

- The patient, or a legally authorized representative, has consented to participate in
the study and has signed the Informed Consent Form

Exclusion Criteria:

- The patient has a known allergy to isopropyl alcohol

- The lesion has been previously biopsied, excised, or traumatized

- The skin is not intact (e.g., open sores, ulcers, bleeding)

- The lesion is within 1 cm of the eye

- The lesion is on mucosal surfaces (e.g., lips, genitals)

- The lesion is on palmar hands

- The lesion is on plantar feet

- The lesion is on or under nails

- The lesion is located on or in an area of visible scarring

- The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Relative sensitivity of enrolling dermatologists after MelaFind use and enrolling dermatologists if MelaFind were not available.

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

Protocol 20111

NCT ID:

NCT01700114

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Melanoma
  • Pigmented Skin Lesions
  • Dermatology
  • Skin Cancer
  • Melanoma
  • MelaFind
  • Melanoma

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
The Johns Hopkins UniversityBaltimore, Maryland  21287
University Hospitals Case Medical CenterCleveland, Ohio  44106
Dermatology Associates of Tallahassee1707 Riggins Road, Tallahassee, Florida  32308
The Dermatology Group, P.C.Verona, New Jersey  07044