Melanoma and Other Malignant Neoplasms of SkinNCT05602337
A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Mutation Burden in Non-lesional Facial Skin of Patients With a Hx of Skin Cancer
An observational study of Melanoma and Other Malignant Neoplasms of Skin, run by DermTech at 1 site in United States.
Trial summary
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate the mutation burden of non-lesional facial skin from subjects with a documented history of numerous basal cell carcinomas, squamous cell carcinomas or melanomas compared to that of subjects with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma and Other Malignant Neoplasms of Skin
- What is being tested?
- Observational Study Only
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 15 Mar 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Immunocompetent subjects: 1. BCC-predominant group: Subjects with a history of 10 or more basal cell carcinomas (BCCs) and at least a 10:1 ratio of BCC to other skin cancer types 2. SCC-predominant group: Subjects with a history of 5 or more squamous cell carcinomas (SCC) and at least a 5:1 ratio of SCC to other skin cancer types 3. Melanoma group: Subjects with at least 3 melanomas (invasive or in situ) 4. Control group: Sex, age (50-70 years) and Fitzpatrick phototype-matched controls SOTR subjects: 5. Solid-organ transplant recipients (SOTR) with a history of at least 5 skin cancers, who are age 50-70 and at least 5-years post-transplant 6. Solid-organ transplant recipients with no more than 1 skin cancer, who are age 50-70 years and at least 5-years post-transplant
Who may be able to join
- For the immunocompetent (non-SOTR) groups, a subject will be eligible if he or she:
- Is at least 18 years of age;
- Is willing to consent to non-invasive adhesive tape sampling and DNA mutation burden analysis;
- Has a history of 10 or more basal cell carcinomas (BCCs) and at least a 10:1 ratio of BCC to other skin cancer types; or
- Has a history of 5 or more squamous cell carcinomas (SCCs) and at least a 5:1 ratio of SCC to other skin cancer types; or
- Has a history of 3 or more melanomas; or
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- For the immunocompetent controls:
- Has no history of skin cancer but is an age, birth sex, and Fitzpatrick phototype match (control) for an enrolled participant.
- For the SOTR groups, a subject will be eligible if he or she:
- Is age 50-70;
- Received a heart, lung, kidney, or liver transplant at least 5 years prior to study enrollment; or
- Has a history of 5 or more keratinocyte carcinomas (BCC or SCC), or a history of 3 or more melanomas following organ transplantation.
- For the SOTR controls:
- Is a transplant recipient age 50-70 with no more than 2 keratinocyte carcinomas.
Who cannot join
- Has applied certain topical medications (corticosteroids, alpha-hydroxy acids, retinoids, antibiotics, etc.) to the skin to be sampled within 30 days of beginning the study;
- Has undergone field therapy for actinic keratoses (e.g. 5-fluorouracil) involving the skin to be sampled within the past 12 months;
- Has a generalized skin disorder not related to skin cancer such as psoriasis, photosensitivity disorder, or eczematous dermatitis affecting the skin to be sampled;
- Has a known allergy to latex rubber or tape adhesives;
- Is currently participating in another investigational study, or has participated in another study within 30 days of initiating the current study;
- Has applied a sunscreen, moisturizer, or other topical to the skin to be sampled that cannot be adequately removed and may therefore compromise sample collection;
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- Has clinical findings which the Investigator determines may put the subject at undue risk or may interfere with the study;
- Has undergone phototherapy or used a tanning bed within 3 months of beginning the study;
- Has used systemic retinoids, chemotherapeutics, or immunotherapy within 3 months of beginning the study;
- Has used an immunosuppressive medication within 3 months of study initiation, such as azathioprine, cyclosporine, methotrexate, or any of the immunosuppressive biological therapies (TNF-inhibitors, etc.);
- Is known or suspected to have a cancer predisposition syndrome (CPS), such as Gorlin syndrome / basal cell nevus syndrome, Xeroderma pigmentosum, Ferguson-Smith syndrome, Oculocutaneous albinism, Epidermolysis bullosa, Epidermodysplasia verruciformis, Fanconi anemia, Rombo syndrome, Bazex-Dupre-Christol syndrome, Bloom syndrome, Werner syndrome, Dyskeratosis congenita, Hereditary Breast and Ovarian Cancer (HBOC) syndrome, Lynch syndrome, etc.;
- Is known or suspected to harbor a pathogenic germline mutation within one or more cancer predisposition genes, such as TP53, CDKN2A, NF1, BAP1, DICER1, FH, SDHD, VHL, etc.; and
- Has a history of skin cancer that cannot be verified.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC
Pittsburgh, Pennsylvania, 15213
Charity Ruhl, LPN, 412-647-2013, ruhlcl@upmc.edu
About this study
Official title: A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Mutation Burden in Non-lesional Facial Skin of Patients With a History of Skin Cancer
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate the mutation burden of non-lesional facial skin from subjects with a documented history of numerous basal cell carcinomas, squamous cell carcinomas or melanomas compared to that of subjects with no history of skin cancer matched for age, sex and Fitzpatrick phototype.
Read the detailed description
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate the mutation burden of non-lesional facial skin from subjects with a documented history of numerous basal cell carcinomas, squamous cell carcinomas or melanomas compared to that of subjects with no history of skin cancer matched for age, sex and Fitzpatrick phototype.
Approximately 20-30 participants will be enrolled in each of six (6) main groups outlined below for a total of 120-180 subjects and controls:
- Being tested
- Observational Study Only
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study OnlyOther
Also called Non-invasive Skin Sampling
Non-invasive Skin Sampling
| Study group | Role | What they receive |
|---|---|---|
| Immunocompetent BCC Subjects | BCC-predominant group Receives: Other: Observational Study Only | |
| Immunocompetent SCC Subjects | SCC-predominant group Receives: Other: Observational Study Only | |
| Immunocompetent MM Subjects | Melanoma group Receives: Other: Observational Study Only | |
| Control | age, sex and Fitzpatrick phototype match Receives: Other: Observational Study Only | |
| Solid Organ Transplantation Recipient - SC | At least 5 skin cancers and at least 5 years post-transplant Receives: Other: Observational Study Only | |
| Solid Organ Transplantation Recipient | No more than 1 skin cancer and at least 5 years post-transplant Receives: Other: Observational Study Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate genomic changes associated with increased risk of skin cancers
Non-invasively assess skin samples collected from facial skin from participants with a history of non-melanoma skin cancers and melanoma skin cancer compared to age, sex and Fitzpatrick phototype controls
Measured: 1- year
Secondary outcomes (1)
Evaluate the potential differences in the number and/or type of mutations in non-lesional skin in solid organ transplant recipients
Non-invasively assess skin samples collected from facial skin from solid organ transplant recipients.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma and Other Malignant Neoplasms of SkinStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- James Rock, Study director, DermTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602337
- Sponsor's protocol ID
- DermTech 2022
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Mutation Burden in Non-lesional Facial Skin of Patients With a History of Skin Cancer
- ClinicalTrials.gov ID
- NCT05602337
- Acronym / sponsor ID
- DermTech 2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- DermTechUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 2 Nov 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.
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate the mutation burden of non-lesional facial skin from subjects with a documented history of numerous basal cell carcinomas, squamous cell carcinomas or melanomas compared to that of subjects with no history of skin cancer matched for age, sex and Fitzpatrick phototype.
Detailed description
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate the mutation burden of non-lesional facial skin from subjects with a documented history of numerous basal cell carcinomas, squamous cell carcinomas or melanomas compared to that of subjects with no history of skin cancer matched for age, sex and Fitzpatrick phototype.
Approximately 20-30 participants will be enrolled in each of six (6) main groups outlined below for a total of 120-180 subjects and controls:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Immunocompetent BCC Subjects | – | Other: Observational Study OnlyBCC-predominant group |
| Immunocompetent SCC Subjects | – | Other: Observational Study OnlySCC-predominant group |
| Immunocompetent MM Subjects | – | Other: Observational Study OnlyMelanoma group |
| Control | – | Other: Observational Study Onlyage, sex and Fitzpatrick phototype match |
| Solid Organ Transplantation Recipient - SC | – | Other: Observational Study OnlyAt least 5 skin cancers and at least 5 years post-transplant |
| Solid Organ Transplantation Recipient | – | Other: Observational Study OnlyNo more than 1 skin cancer and at least 5 years post-transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Immunocompetent subjects: 1. BCC-predominant group: Subjects with a history of 10 or more basal cell carcinomas (BCCs) and at least a 10:1 ratio of BCC to other skin cancer types 2. SCC-predominant group: Subjects with a history of 5 or more squamous cell carcinomas (SCC) and at least a 5:1 ratio of SCC to other skin cancer types 3. Melanoma group: Subjects with at least 3 melanomas (invasive or in situ) 4. Control group: Sex, age (50-70 years) and Fitzpatrick phototype-matched controls SOTR subjects: 5. Solid-organ transplant recipients (SOTR) with a history of at least 5 skin cancers, who are age 50-70 and at least 5-years post-transplant 6. Solid-organ transplant recipients with no more than 1 skin cancer, who are age 50-70 years and at least 5-years post-transplant
Key inclusion criteria (14 listed)
- Is at least 18 years of age;
- Is willing to consent to non-invasive adhesive tape sampling and DNA mutation burden analysis;
- Has a history of 10 or more basal cell carcinomas (BCCs) and at least a 10:1 ratio of BCC to other skin cancer types; or
- Has a history of 5 or more squamous cell carcinomas (SCCs) and at least a 5:1 ratio of SCC to other skin cancer types; or
- Has a history of 3 or more melanomas; or
Key exclusion criteria (13 listed)
- Has applied certain topical medications (corticosteroids, alpha-hydroxy acids, retinoids, antibiotics, etc.) to the skin to be sampled within 30 days of beginning the study;
- Has undergone field therapy for actinic keratoses (e.g. 5-fluorouracil) involving the skin to be sampled within the past 12 months;
- Has a generalized skin disorder not related to skin cancer such as psoriasis, photosensitivity disorder, or eczematous dermatitis affecting the skin to be sampled;
- Has a known allergy to latex rubber or tape adhesives;
- Is currently participating in another investigational study, or has participated in another study within 30 days of initiating the current study;
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 |
|---|---|---|
| Observational Study OnlyAlso: Non-invasive Skin SamplingNon-invasive Skin Sampling | Other | Control, Immunocompetent BCC Subjects, Immunocompetent MM Subjects, Immunocompetent SCC Subjects, Solid Organ Transplantation Recipient, Solid Organ Transplantation Recipient - SC |
Primary outcome
Evaluate genomic changes associated with increased risk of skin cancers
Time frame: 1- year
Non-invasively assess skin samples collected from facial skin from participants with a history of non-melanoma skin cancers and melanoma skin cancer compared to age, sex and Fitzpatrick phototype controls
1 secondary outcome
Evaluate the potential differences in the number and/or type of mutations in non-lesional skin in solid organ transplant recipients
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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
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 and Other Malignant Neoplasms of Skin, 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 14 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Rock, MS MBA (8584504222, jrock@dermtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate genomic changes associated with increased risk of skin cancers (time frame: 1- year). 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 2 Nov 2022.