- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536029
MicroRNA Expression and Function in Cutaneous Malignant Melanoma
September 26, 2007 updated by: Rigshospitalet, Denmark
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2200
- Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pigmented lesion
Exclusion Criteria:
- No pigmented lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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A
Subject with pigmented skin lesion suspect for malignant melanoma
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Glud, Cand.med., Department for Plastic Surgery and Burn Unit
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/j.bjps.2006.10.003. 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. doi: 10.1111/j.1365-2133.2007.07932.x.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 26, 2007
First Submitted That Met QC Criteria
September 26, 2007
First Posted (Estimate)
September 27, 2007
Study Record Updates
Last Update Posted (Estimate)
September 27, 2007
Last Update Submitted That Met QC Criteria
September 26, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2007-0009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.