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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma and Other Malignant Neoplasms of Skin
• Intervention / Treatment: Other: Observational Study Only

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: James Rock, MS MBA; Phone Number: 8584504222; Email: jrock@dermtech.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
      • Contact: Charity Ruhl, LPN; Phone Number: 412-647-2013; Email: ruhlcl@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immunocompetent BCC Subjects; BCC-predominant group	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling
Immunocompetent SCC Subjects; SCC-predominant group	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling
Immunocompetent MM Subjects; Melanoma group	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling
Control; age, sex and Fitzpatrick phototype match	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling
Solid Organ Transplantation Recipient - SC; At least 5 skin cancers and at least 5 years post-transplant	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling
Solid Organ Transplantation Recipient; No more than 1 skin cancer and at least 5 years post-transplant	Other: Observational Study Only; Non-invasive Skin Sampling; Other Names: Non-invasive Skin Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-year

Collaborators and Investigators

• Sponsor: DermTech
• Collaborators: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): November 15, 2024
• Study Completion (Anticipated): March 15, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Neoplasms; Skin Neoplasms
• Other Study ID Numbers: DermTech 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No