Post-Approval Study of MelaFind

NCT01700114 | Terminated

• 1 other identifier: Protocol 20111
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 6

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.

Conditions

Melanoma

Keywords

Pigmented Skin Lesions; Dermatology; Skin Cancer; Melanoma; MelaFind

Outcome Measures

Primary Outcomes (1)

• Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available

  6 years

Secondary Outcomes (1)

• To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.

  6 years

Interventions

MelaFind DEVICE

The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MELA Sciences, Inc.: lead

Study Sites (6)

AboutSkin Dermatology and DermSurgery

Englewood, Colorado, 80113, United States

Location

Dermatology Associates of Tallahassee

Tallahassee, Florida, 32308, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Dermatology Group, P.C.

Verona, New Jersey, 07044, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathology slides of biopsied tissue

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Armand Cognetta, MD

  Dermatology Associates of Tallahassee

  PRINCIPAL INVESTIGATOR

• Timothy Wang, MD

  The John's Hopkins University

  PRINCIPAL INVESTIGATOR

• Meg Gerstenblith, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Nossa, MD

  The Dermatology Group, P.C

  PRINCIPAL INVESTIGATOR

• Arthur Sober, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Joel Cohen, MD

  AboutSkin Dermatology and DermSurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)