Melanoma DetectionTRUSTNCT04563949
DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years
An observational study of Melanoma Detection, run by DermTech at 1 site in United States.
Trial summary
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Melanoma Detection
- What is being tested?
- Repeat Testing
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 15 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who had a DermTech PLA completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma positivity rate of 5%-10% is anticipated.
Who may be able to join
- Males and females the treating physician chose to use the PLA on;
- Presence of a lesion(s) that is suspicious for melanoma and a candidate for surgical biopsy that was previously biopsied with DermTech's adhesive patch biopsy and assessed via PLA;
- Willing to permit subsequent PLA assays to be performed on suspicious lesions;
- Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
- Subjects must be able to complete study visits required by the protocol (subject is not planning to relocate or travel thus prevent attendance at future study visits; and
- Willing to provide informed consent to participate in this trial.
Who cannot join
- Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
- Has an ulcerated or bleeding lesion that could cofound the PLA results;
- Has a suspicious lesion(s) in an area that was previously surgically biopsied;
- The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
- Has an allergy to tape or latex rubber;
- Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study; and
- Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule of events. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Practice Utility Study to Assess DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification. Subjects who had, or will have a DermTech Pigmented Lesion Assay completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma rate of approximately 5% to 10% is anticipated.
Read the detailed description
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification.
Subjects will be consented and enter the trial to have their suspicious lesion(s), biopsied via DermTech's adhesive patch biopsy and assessed with DermTech's non-invasive PLA, and followed up to 2 years per standard of care. Lesions must be photographed and/or the site of the lesion anatomically defined to permit follow-up of the lesion(s) and lesional site(s) during future visits.
Subjects will be followed per standard of care for lesion biopsy, excision, treatment and/or monitoring. Other than DermTech's non-invasive PLA of the lesion(s) no other study procedures will be performed and subjects will be treated according to the standard of care. The subject's medical management team should use standard of care, visual assessment changes (i.e., "ABCDE") and physician judgment for suspicious lesion characterization and monitoring when planning the subject's course of treatment.
- Conditions
- Melanoma Detection
- Being tested
- Repeat Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat TestingOther
Repeat Testing with the PLA will be conducted
| Study group | Role | What they receive |
|---|---|---|
| PLA- | PLA- initially and repeat testing 1-2 years later Receives: Other: Repeat Testing | |
| PLA+ | Not eligible for the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects without surgical biopsy
The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC
Measured: approximately up to 24 months
Secondary outcomes (1)
Results of PLA results compared to biopsy
Expression of genes during the 2-year study. The association of gene expression and algorithm values with melanoma versus non-melanoma will be examined using clinical performance indicators negative predictive value with their respective 95th percentile confidence intervals.
Measured: approximately up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start16 Nov 2017
- Primary completion12 Nov 2020
- Study completion15 Dec 2020
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 DetectionStudies 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
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563949
- Sponsor's protocol ID
- 17-02
- Acronym
- TRUST
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All samples received have been de-identified with a study and subject specific number.
Publications
Ferris LK, Jansen B, Ho J, Busam KJ, Gross K, Hansen DD, Alsobrook JP 2nd, Yao Z, Peck GL, Gerami P. Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy. JAMA Dermatol. 2017 Jul 1;153(7):675-680. doi: 10.1001/jamadermatol.2017.0473.
PubMed 28445578Gerami 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Utility Study to Assess DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years
- ClinicalTrials.gov ID
- NCT04563949
- Acronym / sponsor ID
- TRUST / 17-02
- Conditions
- Melanoma Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- DermTechUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 25 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.
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification. Subjects who had, or will have a DermTech Pigmented Lesion Assay completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma rate of approximately 5% to 10% is anticipated.
Detailed description
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification.
Subjects will be consented and enter the trial to have their suspicious lesion(s), biopsied via DermTech's adhesive patch biopsy and assessed with DermTech's non-invasive PLA, and followed up to 2 years per standard of care. Lesions must be photographed and/or the site of the lesion anatomically defined to permit follow-up of the lesion(s) and lesional site(s) during future visits.
Subjects will be followed per standard of care for lesion biopsy, excision, treatment and/or monitoring. Other than DermTech's non-invasive PLA of the lesion(s) no other study procedures will be performed and subjects will be treated according to the standard of care. The subject's medical management team should use standard of care, visual assessment changes (i.e., "ABCDE") and physician judgment for suspicious lesion characterization and monitoring when planning the subject's course of treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLA- | – | Other: Repeat TestingPLA- initially and repeat testing 1-2 years later |
| PLA+ | – | –Not eligible for the study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who had a DermTech PLA completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma positivity rate of 5%-10% is anticipated.
Key inclusion criteria (6 listed)
- Males and females the treating physician chose to use the PLA on;
- Presence of a lesion(s) that is suspicious for melanoma and a candidate for surgical biopsy that was previously biopsied with DermTech's adhesive patch biopsy and assessed via PLA;
- Willing to permit subsequent PLA assays to be performed on suspicious lesions;
- Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
- Subjects must be able to complete study visits required by the protocol (subject is not planning to relocate or travel thus prevent attendance at future study visits; and
Key exclusion criteria (7 listed)
- Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
- Has an ulcerated or bleeding lesion that could cofound the PLA results;
- Has a suspicious lesion(s) in an area that was previously surgically biopsied;
- The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
- Has an allergy to tape or latex rubber;
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 |
|---|---|---|
| Repeat TestingRepeat Testing with the PLA will be conducted | Other | PLA- |
Primary outcome
Proportion of subjects without surgical biopsy
Time frame: approximately up to 24 months
The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC
1 secondary outcome
Results of PLA results compared to biopsy
Time frame: approximately up to 24 months
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 Mar 2021.
- Background: PubMed 28445578Ferris LK, Jansen B, Ho J, Busam KJ, Gross K, Hansen DD, Alsobrook JP 2nd, Yao Z, Peck GL, Gerami P. Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy. JAMA Dermatol. 2017 Jul 1;153(7):675-680. doi: 10.1001/jamadermatol.2017.0473.
- Background: 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.
- Individual participant dataSharing planned: No. All samples received have been de-identified with a study and subject specific number.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Detection, run by DermTech 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 6 inclusion and 7 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 Mar 2021. 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.
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?
Proportion of subjects without surgical biopsy (time frame: approximately up to 24 months). 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 NCT04563949, 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 26 Mar 2021.