Clinical trial NCT01700114: Post-Approval Study of MelaFind
Official title: Post-Approval Study of MelaFind
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Keywords: Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind
Lead sponsor: MELA Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 487
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions that that meet the Indications for Use and Lesion Inclusion and Exclusion Criteria, including signing the Informed Consent Form, are eligible to participate in this study. This single-arm study has one study group consisting of eligible lesions on eligible patients.

Up to six clinical sites in the US will participate in this study, one in each of the six states in which MelaFind is commercially available. Some of the sites will be located in urban settings, and some will be located in a suburban or rural setting. At least 50% of the sites will new, i.e., they did not participate in the MelaFind pivotal study. Some sites will be academic centers and some private practices.

Brief summary: The purpose of this study is to collect data to describe the real-world use and safety and effectiveness of MelaFind® in a post-approval clinical setting.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
timeFrame: 6 years
Secondary outcomes:
measure: To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.
timeFrame: 6 years
Other outcomes:
Locations:
city: Englewood
country: United States
facility: AboutSkin Dermatology and DermSurgery
state: Colorado
city: Tallahassee
country: United States
facility: Dermatology Associates of Tallahassee
state: Florida
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Dermatology Associates of Tallahassee
name: Armand Cognetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The John's Hopkins University
name: Timothy Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Meg Gerstenblith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Dermatology Group, P.C
name: Robert Nossa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Arthur Sober, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AboutSkin Dermatology and DermSurgery
name: Joel Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: