Early Diagnosis of Melanoma Using Expression Profiling and Non-Invasive Sampling of Skin Cells

NCT00482105 | Terminated

• 1 other identifier: 200614850-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study is divided into distinct sample collection and analysis phases. In the sample collection phase investigators will tape strip lesions that are designated for biopsy because they are suspected for melanoma. No biopsies will be taken solely in support of this study; rather patients that present lesions that are to be biopsied-in the context of the standard of care-will be enrolled in the study and will have that lesion(s) tape stripped before the biopsy procedure. In the second phase of the study, tape strip samples will be extracted and RNA purified and expression profiled by DNA microarray. The gene expression data will be correlated with histopathology with the expectation that an expression classifier that distinguishes suspect lesions from melanoma can be defined. That classifier will be validated in future studies.

Conditions

Melanoma

Keywords

melanoma

Outcome Measures

Primary Outcomes (1)

• A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas.

  1 year

Study Arms (1)

A

OTHER

This research study proposes to use a non-invasive method to capture superficial cells on pigmented skin lesions that are suspected of being early melanomas. This non-invasive "biopsy" technology has been developed and patented by DermTech International. RNA in skin cells captured by this method will be profiled in order to diagnose the nature of the lesion (i.e. malignant melanoma or not). A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas

Other: EGIR Tape

Interventions

EGIR Tape OTHER

Tape stripping is a non-invasive method that allows the recovery of cells

Also known as: Tape stripping (EGIR™)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject will be eligible if he or she:
• Is at least 18 years of age;
• Has a pigmented lesion that is suspected of being a melanoma and requires surgical removal.

You may not qualify if:

• The subject cannot participate in this study if he or she:
• Has used topical medications (corticosteroids, alpha-hydroxyacids, or retinoids) within 30 days of beginning the research study;
• Has generalized skin disorders not related to skin cancer such as psoriasis, photosensitivity disorder or eczema;
• Has allergy to tape or latex rubber.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fu-Tong Liu, M.D. PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)