MicroRNA Expression and Function in Cutaneous Malignant Melanoma

This study has been completed.

Sponsor:

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00536029

First received: September 26, 2007

Last updated: NA

Last verified: September 2007

History: No changes posted

Purpose

Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented >80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.

Condition
Melanoma

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective
Official Title:	MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Skin Pigmentation Disorders

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Enrollment:	68
Study Start Date:	February 2007
Study Completion Date:	June 2007

Groups/Cohorts
Case: A Subject with pigmented skin lesion suspect for malignant melanoma

Eligibility

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

Criteria

Inclusion Criteria:

Pigmented lesion

Exclusion Criteria:

No pigmented lesion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536029

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark, 2200

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Martin Glud, Cand.med.

Department for Plastic Surgery and Burn Unit

More Information

Publications:

Govindan K, Smith J, Knowles L, Harvey A, Townsend P, Kenealy J. Assessment of nurse-led screening of pigmented lesions using SIAscope. J Plast Reconstr Aesthet Surg. 2007;60(6):639-45. Epub 2007 Jan 31.

Haniffa MA, Lloyd JJ, Lawrence CM. The use of a spectrophotometric intracutaneous analysis device in the real-time diagnosis of melanoma in the setting of a melanoma screening clinic. Br J Dermatol. 2007 Jun;156(6):1350-2.

Moncrieff M, Cotton S, Claridge E, Hall P. Spectrophotometric intracutaneous analysis: a new technique for imaging pigmented skin lesions. Br J Dermatol. 2002 Mar;146(3):448-57.

ClinicalTrials.gov Identifier:	NCT00536029 History of Changes
Other Study ID Numbers:	H-C-2007-0009
Study First Received:	September 26, 2007
Last Updated:	September 26, 2007
Health Authority:	Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:

Melanoma
SIAscope
pigmented skin lesions

Additional relevant MeSH terms:

Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type

Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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