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

Inclusion Criteria:

For the immunocompetent (non-SOTR) groups, a subject will be eligible if he or she:

1. Is at least 18 years of age;
2. Is willing to consent to non-invasive adhesive tape sampling and DNA mutation burden analysis;
3. 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
4. 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
5. Has a history of 3 or more melanomas; or

   For the immunocompetent controls:
6. 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:
7. Is age 50-70;
8. Received a heart, lung, kidney, or liver transplant at least 5 years prior to study enrollment; or
9. 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:
10. Is a transplant recipient age 50-70 with no more than 2 keratinocyte carcinomas.

Exclusion Criteria:

1. 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;
2. Has undergone field therapy for actinic keratoses (e.g. 5-fluorouracil) involving the skin to be sampled within the past 12 months;
3. Has a generalized skin disorder not related to skin cancer such as psoriasis, photosensitivity disorder, or eczematous dermatitis affecting the skin to be sampled;
4. Has a known allergy to latex rubber or tape adhesives;
5. Is currently participating in another investigational study, or has participated in another study within 30 days of initiating the current study;
6. 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;
7. Has clinical findings which the Investigator determines may put the subject at undue risk or may interfere with the study;
8. Has undergone phototherapy or used a tanning bed within 3 months of beginning the study;
9. Has used systemic retinoids, chemotherapeutics, or immunotherapy within 3 months of beginning the study;
10. 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.);
11. 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.;
12. 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
13. Has a history of skin cancer that cannot be verified.