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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 | Clinical Trials | Clareo Health

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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

NCT05602337•DermTech

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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.
+2 more criteria

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.);
+3 more criteria

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

November 15, 2022

Primary Completion Date

November 15, 2024

Completion Date

March 15, 2025

Last Updated

November 2, 2022

Enrollment

180

ESTIMATED participants

Conditions

Melanoma and Other Malignant Neoplasms of Skin

Interventions

Observational Study Only

OTHER

Contacts

James Rock, MS MBA

CONTACT

8584504222 jrock@dermtech.com

Susan Huynh

CONTACT

8584504222 susan.huynh@dermtech.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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