Skin LesionPhase 1NCT05418959
Genetic Risk Stratification of Pediatric Skin Lesions
A Phase 1 study testing DermTech PLA noninvasive adhesive biopsy in people with Skin Lesion and Nevus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis. Read more about this study
- Who is it for?
- Ages 0 to 20 years
- Conditions the study is for
- Skin Lesion, Nevus
- What is being tested?
- DermTech PLA noninvasive adhesive biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 0 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 20 years of age or younger.
- Subjects or parents willing and able to give informed consent, and assent as appropriate
- Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months
Who cannot join
- Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed
- Bleeding or ulcerated lesions
- Previously biopsied, scarred, or known melanoma lesions
- Presence of active psoriasis/eczema/other skin condition in area to be biopsied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.
Read the detailed description
Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.
- Conditions
- Skin Lesion, Nevus
- Being tested
- DermTech PLA noninvasive adhesive biopsy
- Medical subject headings
- Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermTech PLA noninvasive adhesive biopsyDiagnostic test
The clinician will firmly press the DermTech noninvasive adhesive on the lesion and use their thumb to make five circular motions on the lesion. The adhesive patch will then be pulled off of the area. This will be repeated for an additional three patches.
| Study group | Role | What they receive |
|---|---|---|
| DermTech PLA noninvasive adhesive biopsy | Experimental | Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells. Receives: Diagnostic Test: DermTech PLA noninvasive adhesive biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of PRAME genetic marker.
Presence or absence of PRAME genetic marker from PLA test
Measured: 1 day
Presence or absence of LINC genetic marker.
Presence or absence of LINC genetic marker from PLA test
Measured: 1 da7
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
No. of adverse events from adhesive skin biopsy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-invasive adhesive biopsies of suspicious skin lesions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Hawryluk, Massachusetts General Hospital
- Investigators
- Elena B Hawryluk, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418959
- Sponsor's protocol ID
- 2022P001412
- Status last verified
- May 2026
- First submitted
- 9 Jun 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansen, B., Dobak, J. (2019) The Pigmented Lesion Assay Breakthrough: Enhanced Early Melanoma Detection with a Non-Invasive Gene Expression Test. DermTech, Inc. retrieved 4/11/20 from: https://dermtech.com/wp-content/uploads/PLA-TA.pdf
Brouha B, Ferris LK, Skelsey MK, Peck G, Moy R, Yao Z, Jansen B. Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study. J Drugs Dermatol. 2020 Mar 1;19(3):257-262. No abstract available.
PubMed 32550693
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk Stratification of Pediatric Skin Lesions
- ClinicalTrials.gov ID
- NCT05418959
- Acronym / sponsor ID
- 2022P001412
- Conditions
- Skin Lesion, Nevus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Jun 2022 (actual)
- 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.
A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.
Detailed description
Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-invasive adhesive biopsies of suspicious skin lesions.
| Arm | Type | Receives |
|---|---|---|
| DermTech PLA noninvasive adhesive biopsy | Experimental | Diagnostic Test: DermTech PLA noninvasive adhesive biopsyPrior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells. |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 20 years of age or younger.
- Subjects or parents willing and able to give informed consent, and assent as appropriate
- Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months
Key exclusion criteria (4 listed)
- Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed
- Bleeding or ulcerated lesions
- Previously biopsied, scarred, or known melanoma lesions
- Presence of active psoriasis/eczema/other skin condition in area to be biopsied
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 |
|---|---|---|
| DermTech PLA noninvasive adhesive biopsyThe clinician will firmly press the DermTech noninvasive adhesive on the lesion and use their thumb to make five circular motions on the lesion. The adhesive patch will then be pulled off of the area. This will be repeated for an additional three patches. | Diagnostic test | DermTech PLA noninvasive adhesive biopsy |
Primary outcome
Presence or absence of PRAME genetic marker.
Time frame: 1 day
Presence or absence of PRAME genetic marker from PLA test
Presence or absence of LINC genetic marker.
Time frame: 1 da7
Presence or absence of LINC genetic marker from PLA test
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- BackgroundJansen, B., Dobak, J. (2019) The Pigmented Lesion Assay Breakthrough: Enhanced Early Melanoma Detection with a Non-Invasive Gene Expression Test. DermTech, Inc. retrieved 4/11/20 from: https://dermtech.com/wp-content/uploads/PLA-TA.pdf
- Background: PubMed 32550693Brouha B, Ferris LK, Skelsey MK, Peck G, Moy R, Yao Z, Jansen B. Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study. J Drugs Dermatol. 2020 Mar 1;19(3):257-262. No abstract available.
- Individual participant dataSharing planned: No
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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.
Elena B Hawryluk, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DermTech PLA noninvasive adhesive biopsy in people with Skin Lesion and Nevus, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Presence or absence of PRAME genetic marker. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418959, which also lists 2 linked publications.
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 22 May 2026.