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

DermTech1 个研究点分布在 1 个国家目标入组 180 人2022年11月15日

概览

简要总结

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.

详细描述

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:

注册库

clinicaltrials.gov

开始日期

2022年11月15日

结束日期

2025年3月15日

最后更新

3年前

研究类型

Observational

性别

All

研究者

发起方

DermTech

责任方

Sponsor

入排标准

入选标准

•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;

排除标准

•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.);

结局指标

主要结局

Evaluate genomic changes associated with increased risk of skin cancers

时间窗: 1- year

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