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Trial registered on ANZCTR


Registration number
ACTRN12612000507886
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
10/05/2012
Date last updated
10/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A tape stripping study for early diagnosis of melanoma.
Scientific title
Early diagnosis of melanoma using expression profiling and non-invasive sampling of skin cells in adults with a pigmented lesion suspected of being a melanoma
Secondary ID [1] 280368 0
www.clinicaltrials.gov - NCT00482105
The US site was terminated but the Australian sites were completed.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 286342 0
Condition category
Condition code
Skin 286587 286587 0 0
Dermatological conditions
Cancer 286588 286588 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284736 0
Diagnosis / Prognosis
Comparator / control treatment
All participants will have tape stripping procedure on a site of normal skin to act as the control group. The same tape stripping process will apply, collecting a total of 4 strips from a site of normal skin.
Control group
Active

Outcomes
Primary outcome [1] 287009 0
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.
Timepoint [1] 287009 0
Until approximately 30 melanomas and 30 benign lesions are collected to construct a classifier (approximately over a 1 year period).
Secondary outcome [1] 297192 0
Analysis of selected lesion RNA samples by DNA microscopy.
Timepoint [1] 297192 0
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).
Secondary outcome [2] 297193 0
Correlation of gene expression data with histopathology (from the whole lesion biopsy).
Timepoint [2] 297193 0
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).
Secondary outcome [3] 297194 0
Creation of candidate expression classifier for diagnosis of melanoma
Timepoint [3] 297194 0
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).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 4276 0
United States of America
State/province [1] 4276 0

Funding & Sponsors
Funding source category [1] 285160 0
Commercial sector/Industry
Name [1] 285160 0
Dermtech International
Country [1] 285160 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Dermtech International
Address
1020 Prospect Street
Suite 301
La Jolla, CA, 92037
Country
United States of America
Secondary sponsor category [1] 284023 0
None
Name [1] 284023 0
Address [1] 284023 0
Country [1] 284023 0
Other collaborator category [1] 260775 0
Commercial sector/Industry
Name [1] 260775 0
Novotech (Australia) Pty Ltd
Address [1] 260775 0
Level 3, 235 Pyrmont Street
Pyrmont NSW 2009
Country [1] 260775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287173 0
Alfred Health Research and Ethics Unit
Ethics committee address [1] 287173 0
OFFICE OF ETHICS & RESEARCH GOVERNANCE - Ground Floor, Linay Pavilion, The Alfred
Commercial Road
Prahan VIC 3181
Ethics committee country [1] 287173 0
Australia
Date submitted for ethics approval [1] 287173 0
01/06/2009
Approval date [1] 287173 0
08/04/2010
Ethics approval number [1] 287173 0
1/09/0181
Ethics committee name [2] 287174 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [2] 287174 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [2] 287174 0
Australia
Date submitted for ethics approval [2] 287174 0
01/08/2008
Approval date [2] 287174 0
14/11/2008
Ethics approval number [2] 287174 0
X08-0254

Summary
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.
Trial website
Trial related presentations / publications
Noninvasive genomic detection of melanoma. W. Wachsman, V. Morhenn, T. Palmer, L. Walls, T. Hata, J. Zalla, R. Scheinberg, H. Sofen, S. Mraz, K. Gross,. Rabinovitz, D. Polsky and S. Chang. British Journal of Dermatology 2011 164, pp797–806
Public notes

Contacts
Principal investigator
Name 34097 0
Address 34097 0
Country 34097 0
Phone 34097 0
Fax 34097 0
Email 34097 0
Contact person for public queries
Name 17344 0
Cheryl Peters
Address 17344 0
DermTech International
1020 Prospect Street, Suite 301
Jolla, CA 92037-0068
Country 17344 0
United States of America
Phone 17344 0
+1 (858) 450-4222
Fax 17344 0
+1 (858) 200-3877
Email 17344 0
[email protected]
Contact person for scientific queries
Name 8272 0
Sherman Chang
Address 8272 0
DermTech International
3030 Bunker Hill Street, Suite 218
San Diego, CA 92109-5754
Country 8272 0
United States of America
Phone 8272 0
+1 858 952-5302
Fax 8272 0
+ 1 (858) 952-5330
Email 8272 0
[email protected]

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