None listed
Conditions
Brief summary
This study evaluates a new non-invasive technique for early diagnosis of melanoma. Who is it for? You may be eligible to join this study if you are at least 18 years old and have a pigmented lesion that is suspected of being a melanoma which requires surgical removal. Trial details: This research study proposes to use a novel non-invasive method called Epidermal Genetic Information Retrieval or EGIR to assess skin lesions that are suspicious for melanoma. The method of retrieval is via tape stripping. Tape stripping allows recovery of cells of the upper epidermis (superficial most skin layer). These skin cells will be studied to identify markers capable of distinguishing between melanoma and benign (harmless) pigmented lesions. Unlike standard biopsies, tape stripping is non-invasive, rapid, easy to perform and painless. Therefore, the identification of such markers by this method could help physicians determine the nature of suspicious lesions of the skin without having to perform a biopsy. Tape stripping has been tested previously and has shown promise in identifying markers for other skin disorders and is now being tested through this research study for melanoma. All participants in this study will undergo collection of skin samples via the tape stripping procedure. The tape (0.7inches in diameter), similar to a band-Aid will be applied to the skin lesion and rubbed in circular motions. 4 skin tapes will be placed on the same skin lesion. A normal looking skin area (an area that does not have a lesion) will be used as a comparator. After the skin taping procedure is completed, the skin lesion will be biopsied or removed as per the normal clinical practice. The tape strips will be couriered to the Sponsor DermTech International where they will be analysed. The Biopsy specimen will be sent to a nominated pathologist for this study and results will be sent back to the investigator. The tissue slides will be sent to an independent pathologist for a second review.
Interventions
Lesions suspected for melanoma will be tape stripped via the EGIR tape stripping method prior to biopsy. The tape will be applied to the site and briskly rubbed for a minimum of 15 circular motions and then removed. This process will be repeated 4 times so that 4 tape strips are collected altogether. Participants will have only one study visit in which this will be conducted. After the tape stripping procedure is completed, the lesion will be biopsied according to local standard procedure.
Sponsors
Dermtech International
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The subject will be eligible if he or she: (i) Is at least 18 years of age; (ii) Has a pigmented lesion that is suspected of being a melanoma and requires surgical removal with a preoperative biopsy diameter of greater than and/or equal to 4 mm. Multiple lesions must be at least 4 mm apart; (iii) The subject is willing to follow standard of care provided by the investigator and/or designee.
Exclusion criteria
The subject cannot participate in this study if he or she: (i) Has used topical medications (corticosteroids, alpha-hydroxyacids, retinoids, antibiotics) or systemic steroids within 30 days of beginning the research study; (ii) Has generalized skin disorders not related to skin cancer such as psoriasis, photosensitivity disorder or eczema; (iii) Has allergy to tape or latex rubber; (iv) Subject is currently participating, or has participated in the 30 days prior to study, in an investigational (OTC, RX or device) study; (v) Has used sun screen and/or moisturizer within 24 hours of study entry; (vi) Subject with other abnormal clinical findings which the Investigator feels may put the Subject at undue risk or may interfere with the study results. (vii) Has an advanced stage lesion (e.g. ulcerated, bleeding, oozing).
Outcome results
None listed