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

Trial Title: 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

NCT ID: NCT05602337

Condition: Melanoma and Other Malignant Neoplasms of Skin

Conditions: Official terms:
Neoplasms
Skin Neoplasms

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Observational Study Only
Description: Non-invasive Skin Sampling
Arm group label: Control
Arm group label: Immunocompetent BCC Subjects
Arm group label: Immunocompetent MM Subjects
Arm group label: Immunocompetent SCC Subjects
Arm group label: Solid Organ Transplantation Recipient
Arm group label: Solid Organ Transplantation Recipient - SC

Other name: Non-invasive Skin Sampling

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.

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:

Criteria for eligibility:

Study pop:
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

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: UPMC

Address:
City: Pittsburgh
Zip: 15213
Country: United States

Contact:
Last name: Charity Ruhl, LPN

Phone: 412-647-2013
Email: ruhlcl@upmc.edu

Start date: November 15, 2022

Completion date: March 15, 2025

Lead sponsor:
Agency: DermTech
Agency class: Other

Collaborator:
Agency: University of Pittsburgh
Agency class: Other

Source: DermTech

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05602337