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MicroRNA Expression and Function in Cutaneous Malignant Melanoma

NCT ID: NCT00536029

Last Updated: 2007-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Keywords

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Melanoma SIAscope pigmented skin lesions

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Subject with pigmented skin lesion suspect for malignant melanoma

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pigmented lesion

Exclusion Criteria

* No pigmented lesion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Martin Glud, Cand.med.

Role: PRINCIPAL_INVESTIGATOR

Department for Plastic Surgery and Burn Unit

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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. doi: 10.1016/j.bjps.2006.10.003. Epub 2007 Jan 31.

Reference Type BACKGROUND
PMID: 17485052 (View on PubMed)

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. doi: 10.1111/j.1365-2133.2007.07932.x.

Reference Type BACKGROUND
PMID: 17535234 (View on PubMed)

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. doi: 10.1046/j.1365-2133.2002.04569.x.

Reference Type BACKGROUND
PMID: 11952545 (View on PubMed)

Other Identifiers

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H-C-2007-0009

Identifier Type: -

Identifier Source: org_study_id