A tape stripping study for early diagnosis of melanoma.

Not Applicable

Completed

• Conditions: Melanoma; Skin - Dermatological conditions; Cancer - Malignant melanoma

• Registration Number: ACTRN12612000507886
• Lead Sponsor: Dermtech International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To create a sample set of pigmented skin lesions and control skin using a non-invasive tape stripping procedure. The RNA recovered will be correlated with the histopathology in an aim to create a classifier for potential non invasive diagnosis of melanoma.[Until approximately 30 melanomas and 30 benign lesions are collected to construct a classifier (approximately over a 1 year period).]

Secondary Outcome Measures

Name	Time	Method
Analysis of selected lesion RNA samples by DNA microscopy.[Analysis will be performed after sufficient number of sample sets are collected. Approximately 30 melanomas and 30 benign lesions are needed to construct a classifier (approximately over a 1 year period).];Correlation of gene expression data with histopathology (from the whole lesion biopsy).[Analysis will be performed after sufficient number of sample sets are collected. Approximately 30 melanomas and 30 benign lesions are needed to construct a classifier (approximately over a 1 year period).];Creation of candidate expression classifier for diagnosis of melanoma[This will be done after sufficient number of sample sets are collected and analysed. Approximately 30 melanomas and 30 benign lesions are needed to construct a classifier (approximately over a 1 year period).]