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

This study has been terminated.
(Withdrawn per sponsor and Investigator)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00482105
First received: May 31, 2007
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Melanoma
Other: EGIR Tape

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Melanoma Using Expression Profiling and Non-Invasive Sampling of Skin Cells

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: March 2007
Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
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
Tape stripping is a non-invasive method that allows the recovery of cells
Other Name: Tape stripping (EGIR™)

  Hide Detailed Description

Detailed Description:

This is a multi-center study, sponsored by Derm Tech (DTI) International.

Specific Aims of the study

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. This assay and more in particular the diagnostic gene expression profile are considered candidate because the profile would have to be validated (i.e. proven to be diagnostic) in larger clinical trials. Secondary outcomes could include tests for diagnosis and prognosis of a variety of pigmented skin lesions.

Specific Aim 1: To create a sample set of pigmented skin lesions. Each sample consisting of:

  1. RNA recovered by tape stripping the superficial epidermis overlying the lesion (tape stripping will also be used to recover RNA from normal skin areas and benign nevi as controls).
  2. A standard biopsy of the same lesion and accompanying histology and diagnosis. Biopsies would be taken after tape stripping and subjected to standard histopathologic analysis, which would provide a "gold standard" diagnosis. These diagnoses could then be correlated with the data generated in Specific

Aim 2.

This specific aim is composed of three individual aims:

  1. Analysis of selected lesion RNA samples by DNA microarray.
  2. Correlation of gene expression data with histopathology.
  3. Creation of a candidate expression classifier for diagnosis of melanoma.

Tape stripping (commercialized as a method for RNA recovery as Epidermal Genetic Information Retrieval or EGIR™) is a non-invasive method that allows recovery of cells comprising and associated with the upper epidermis [4]. The feasibility of non-invasive sampling of human epidermis by sequential adhesive tape stripping was shown by Morhenn et al [4]. Their work showed that tape stripping of skin yielded sufficient RNA for analysis by ribonuclease protection assay to detect specific RNA species, including those known to be at low abundance.

4. Therapeutically removed tissue will be collected

Tape-stripping procedure will be performed before all biopsy procedures. The tape will be applied to the site and briskly rubbed with the blunt rounded end of a marker or plastic test tube in a circular motion. A minimum of 15 circular motions must be completed before the tape is removed. To accommodate the fact that many sites will be smaller than the diameter of the tape, care will be taken to apply the tape only to the lesion or control site and not to the surrounding normal epidermis. The border of the lesion will be demarcated on the tape with a surgical marker; when the tapes are processed for RNA extraction, the marking will allow removal of tape that did not contact the lesion (and that might harbor normal epidermis). A total of 4 tapes will be used to sample a site greater than or equal to 6 mm in diameter. Preliminary data obtained from DTI show that lesions less than 6 mm in diameter may require up to 8 tapes to recover RNA. Tape stripping will also be performed on one normal appearing skin area (preferably; upper back or mastoid process) as well as one benign nevus (if available) to use as a comparison. After sampling, the tapes will be stored at -20oC or below. The tapes will be shipped to DTI on dry ice, by express mail, for analysis.

Biopsy After the tape-stripping procedure is completed, the whole lesion will be surgically excised according to standard clinical practice. The biopsy is a standard of care procedure that would be conducted regardless of the research. All tissues removed are fixed in formalin and sent to a histopathology laboratory, where they are embedded in paraffin and sectioned for histopathological analysis. Pathology results will be collected for distinguishing diagnosis. The subject pathology reports will be identified with the assigned unique subject identifiers prior to use in the study to protect subject identity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482105

Locations
United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Fu-Tong Liu, M.D. PhD UC Davis
  More Information

No publications provided

Responsible Party: Fu-Tong Liu, M.D., Ph.D., UC Davis
ClinicalTrials.gov Identifier: NCT00482105     History of Changes
Other Study ID Numbers: 200614850-1
Study First Received: May 31, 2007
Last Updated: May 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 20, 2014