Melanoma (Skin)NCT04550000
Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
An observational study of Melanoma (Skin) and Pigmented Skin, run by DermTech at 2 sites in United States.
Trial summary
A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Melanoma (Skin), Pigmented Skin, Nevus
- How many people
- 652 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 15 Jul 2022
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: This study will enroll all patients who present to a physician for examination of lesions suspicsion for melanoma
Who may be able to join
- Males and females at least 21 years of age
- Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
- The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
- Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
- Willing to have DermTech adhesive patch biopsies performed
- Must be able to complete study procedures as required by the protocol
- Willing to provide informed consent to participate in this trial
Who cannot join
- Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
- Has an ulcerated or bleeding lesion that could confound the biopsy results
- Has a suspicious lesion(s) in an area that was previously surgically biopsied
- Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
- The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
- Has a known sensitivity to adhesive patches
Show all 10Show fewer
- Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study
- Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)
- Suspected non-melanoma skin cancer
- Patients with contraindication(s) to surgical biopsy -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatologic Surgery Center
Chevy Chase, Maryland, 20185
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Multi-center Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.
Read the detailed description
A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.
- Conditions
- Melanoma (Skin), Pigmented Skin, Nevus
- Keywords
- Pigmented Lesion Assay (PLA), DermTech
- Medical subject headings
- Melanoma, Pigmentation Disorders, Nevus
What is being measured
The primary outcome is the main question the study is designed to answer.
Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings.
gene expression associated with melanoma vs non-melanoma compared to surgical biopsy
Measured: Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical biopsy reports. Analysis results are expected in 2021
Up to 1000 samples will be compared to biopsy results for DNA mutations
Dna mutations associated with more aggressive forms of melanoma
Measured: Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical reports and DNA mutation analysis. Analysis results are expected in 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Mar 2019
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
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 Melanoma (Skin)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Rock, Study director, DermTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550000
- Sponsor's protocol ID
- 19-01
- Status last verified
- Mar 2021
- First submitted
- 9 Sep 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao Z, Allen T, Oakley M, Samons C, Garrison D, Jansen B. Analytical Characteristics of a Noninvasive Gene Expression Assay for Pigmented Skin Lesions. Assay Drug Dev Technol. 2016 Aug;14(6):355-63. doi: 10.1089/adt.2016.724.
PubMed 27505074Gerami P, Yao Z, Polsky D, Jansen B, Busam K, Ho J, Martini M, Ferris LK. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017 Jan;76(1):114-120.e2. doi: 10.1016/j.jaad.2016.07.038. Epub 2016 Oct 1.
PubMed 27707590
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
- ClinicalTrials.gov ID
- NCT04550000
- Acronym / sponsor ID
- 19-01
- Conditions
- Melanoma (Skin), Pigmented Skin, Nevus
- Keywords
- Pigmented Lesion Assay (PLA), DermTech
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- DermTechUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 16 Sep 2020 (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 multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.
Detailed description
A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will enroll all patients who present to a physician for examination of lesions suspicsion for melanoma
Key inclusion criteria (7 listed)
- Males and females at least 21 years of age
- Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
- The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
- Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
- Willing to have DermTech adhesive patch biopsies performed
Key exclusion criteria (10 listed)
- Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
- Has an ulcerated or bleeding lesion that could confound the biopsy results
- Has a suspicious lesion(s) in an area that was previously surgically biopsied
- Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
- The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
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
Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings.
Time frame: Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical biopsy reports. Analysis results are expected in 2021
gene expression associated with melanoma vs non-melanoma compared to surgical biopsy
Up to 1000 samples will be compared to biopsy results for DNA mutations
Time frame: Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical reports and DNA mutation analysis. Analysis results are expected in 2021
Dna mutations associated with more aggressive forms of melanoma
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 28 Oct 2022.
- Results publication: PubMed 27505074Yao Z, Allen T, Oakley M, Samons C, Garrison D, Jansen B. Analytical Characteristics of a Noninvasive Gene Expression Assay for Pigmented Skin Lesions. Assay Drug Dev Technol. 2016 Aug;14(6):355-63. doi: 10.1089/adt.2016.724.
- Results publication: PubMed 27707590Gerami P, Yao Z, Polsky D, Jansen B, Busam K, Ho J, Martini M, Ferris LK. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017 Jan;76(1):114-120.e2. doi: 10.1016/j.jaad.2016.07.038. Epub 2016 Oct 1.
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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. This study is not recruiting at the moment.
James Rock study director
DermTech
2 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 (Skin) and Pigmented Skin, run by DermTech at 2 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 7 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings. (time frame: Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical biopsy reports. Analysis results are expected in 2021). 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 NCT04550000, 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 28 Oct 2022.