MelanomaDermTechNCT00482105
Early Diagnosis of Melanoma Using Expression Profiling and Non-Invasive Sampling of Skin Cells
A study testing EGIR Tape in people with Melanoma, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- EGIR Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
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.
Read the 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:
- 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).
- 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:
- Analysis of selected lesion RNA samples by DNA microarray.
- Correlation of gene expression data with histopathology.
- 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.
- 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.
- Conditions
- Melanoma
- Being tested
- EGIR Tape
- Keywords
- melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGIR TapeOther
Also called Tape stripping (EGIR™)
Tape stripping is a non-invasive method that allows the recovery of cells
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: EGIR Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Withdrawn per sponsor and Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Tong Liu, M.D. PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482105
- Sponsor's protocol ID
- 200614850-1
- Acronym
- DermTech
- Status last verified
- Apr 2015
- First submitted
- 31 May 2007
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Melanoma Using Expression Profiling and Non-Invasive Sampling of Skin Cells
- ClinicalTrials.gov ID
- NCT00482105
- Acronym / sponsor ID
- DermTech / 200614850-1
- Conditions
- Melanoma
- Keywords
- melanoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn per sponsor and Investigator
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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:
- Analysis of selected lesion RNA samples by DNA microarray.
- Correlation of gene expression data with histopathology.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: EGIR TapeThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years of age;
- Has a pigmented lesion that is suspected of being a melanoma and requires surgical removal.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGIR TapeAlso: Tape stripping (EGIR™)Tape stripping is a non-invasive method that allows the recovery of cells | Other | A |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Withdrawn per sponsor and Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Tong Liu, M.D. PhD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGIR Tape in people with Melanoma, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Withdrawn per sponsor and Investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.