MelanomaNCT01700114
Post-Approval Study of MelaFind
An observational study of Melanoma, run by MELA Sciences, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- MelaFind
- Type of treatment
- Medical device
- How many people
- 487 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Johns Hopkins University
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
AboutSkin Dermatology and DermSurgery
Englewood, Colorado, 80113
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32308
The Dermatology Group, P.C.
Verona, New Jersey, 07044
About this study
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- MelaFind
- Keywords
- Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelaFindDevice
The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: FDA withdrew requirement to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- MELA Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armand Cognetta, MD, Principal investigator, Dermatology Associates of TallahasseeTimothy Wang, MD, Principal investigator, The John's Hopkins UniversityMeg Gerstenblith, MD, Principal investigator, University Hospitals Cleveland Medical CenterRobert Nossa, MD, Principal investigator, The Dermatology Group, P.CArthur Sober, MD, Principal investigator, Massachusetts General HospitalJoel Cohen, MD, Principal investigator, AboutSkin Dermatology and DermSurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700114
- Sponsor's protocol ID
- Protocol 20111
- Status last verified
- Mar 2016
- First submitted
- 2 Oct 2012
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of MelaFind
- ClinicalTrials.gov ID
- NCT01700114
- Acronym / sponsor ID
- Protocol 20111
- Conditions
- Melanoma
- Keywords
- Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: FDA withdrew requirement to complete study
- Enrolment
- 487 participants (actual)
- Lead sponsor
- MELA Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelaFindThe device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy. | Device | – |
Primary outcome
Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
Time frame: 6 years
1 secondary outcome
To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.
Time frame: 6 years
Results and safety
The study was stopped early (reason given: FDA withdrew requirement to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Melanoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 3
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Advanced (Unresectable or Metastatic) Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）
Melanoma (Excluding Uveal Melanoma)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Cognetta, MD principal investigator
Dermatology Associates of Tallahassee
Timothy Wang, MD principal investigator
The John's Hopkins University
Meg Gerstenblith, MD principal investigator
University Hospitals Cleveland Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by MELA Sciences, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: FDA withdrew requirement to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016; AzTrials last refreshed its copy on 28 Oct 2026.