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
1 other identifier
observational
180
1 country
1
Brief 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 no history of skin cancer matched for age, sex and Fitzpatrick phototype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2025
CompletedNovember 2, 2022
October 1, 2022
2 years
October 27, 2022
October 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
1-year
Study Arms (6)
Immunocompetent BCC Subjects
BCC-predominant group
Immunocompetent SCC Subjects
SCC-predominant group
Immunocompetent MM Subjects
Melanoma group
Control
age, sex and Fitzpatrick phototype match
Solid Organ Transplantation Recipient - SC
At least 5 skin cancers and at least 5 years post-transplant
Solid Organ Transplantation Recipient
No more than 1 skin cancer and at least 5 years post-transplant
Interventions
Non-invasive Skin Sampling
Eligibility Criteria
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
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DermTechlead
- University of Pittsburghcollaborator
Study Sites (1)
UPMC
Pittsburgh, Pennsylvania, 15213, United States
Biospecimen
Non-invasively collected skins samples will be harvested with adhesive patches and stored for batch analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Rock
DermTech
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 2, 2022
Study Start
November 15, 2022
Primary Completion
November 15, 2024
Study Completion
March 15, 2025
Last Updated
November 2, 2022
Record last verified: 2022-10