Clinically Atypical Pigmented Skin LesionNCT01700101
MelaFind Evaluations for Patients With Multiple Nevi
An observational study of Clinically Atypical Pigmented Skin Lesion, run by MELA Sciences, Inc..
Trial summary
We have added objectives 4-6 to our updated study: Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinically Atypical Pigmented Skin Lesion
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 2014
- 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: Patients who have at least one lesion that meets the inclusion/exclusion criteria (see eligibility criteria below) AND each lesion enrolled must be clinically atypical (i.e., contain at least one of the following ABCDEPRU characteristics: Asymmetry, Border irregularity, Color variegation, Diameter < 6 mm, Evolving, Patient's concern, Regression, Ugly duckling). Lesions should be selected to have characteristics that may affect the repeatability of lesion scores: anatomic site (often exposed to UV - sun or tanning beds - or not; sun-damage may affect the repeatability); lesion diameter (6 mm, e.g. ~5 mm or > 6 mm, e.g., 10 mm); and melanin content relative to normal skin (dark pigmentation or light pigmentation). A maximum of 8 lesions may be enrolled per patient
Who may be able to join
- The lesion is pigmented (i.e., melanin, keratin, blood)
- The diameter of the pigmented area is not < 2 mm, and not > 22 mm
- The lesion is accessible to the MelaFind
- The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form;
- Cutaneous lesions that meet any of the following exclusion criteria will not be accepted:
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
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- 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)
About this study
We have added objectives 4-6 to our updated study:
Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient.
Read more
Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions.
Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.
Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.
Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.
Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions
Measured: 1 month
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 completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Atypical Pigmented Skin LesionStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- MELA Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700101
- Sponsor's protocol ID
- 20123
- Status last verified
- Aug 2014
- First submitted
- 2 Oct 2012
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MelaFind Evaluations for Patients With Multiple Nevi
- ClinicalTrials.gov ID
- NCT01700101
- Acronym / sponsor ID
- 20123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- MELA Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (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.
We have added objectives 4-6 to our updated study:
Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient.
Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions.
Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.
Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.
Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.
Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have at least one lesion that meets the inclusion/exclusion criteria (see eligibility criteria below) AND each lesion enrolled must be clinically atypical (i.e., contain at least one of the following ABCDEPRU characteristics: Asymmetry, Border irregularity, Color variegation, Diameter < 6 mm, Evolving, Patient's concern, Regression, Ugly duckling). Lesions should be selected to have characteristics that may affect the repeatability of lesion scores: anatomic site (often exposed to UV - sun or tanning beds - or not; sun-damage may affect the repeatability); lesion diameter (6 mm, e.g. ~5 mm or > 6 mm, e.g., 10 mm); and melanin content relative to normal skin (dark pigmentation or light pigmentation). A maximum of 8 lesions may be enrolled per patient
Key inclusion criteria (5 listed)
- The lesion is pigmented (i.e., melanin, keratin, blood)
- The diameter of the pigmented area is not < 2 mm, and not > 22 mm
- The lesion is accessible to the MelaFind
- 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.
Primary outcome
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Atypical Pigmented Skin Lesion, run by MELA Sciences, Inc..
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: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions (time frame: 1 month). 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 26 Aug 2014.