MelanomaNCT00536029
MicroRNA Expression and Function in Cutaneous Malignant Melanoma
An observational study of Melanoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to Jun 2007
- Phase
- Observational
- 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
- Pigmented lesion
Who cannot join
- No pigmented lesion
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melanoma
- Keywords
- Melanoma, SIAscope, pigmented skin lesions
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Subject with pigmented skin lesion suspect for malignant melanoma |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startFeb 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Martin Glud, Cand.med., Principal investigator, Department for Plastic Surgery and Burn Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536029
- Sponsor's protocol ID
- H-C-2007-0009
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17485052Haniffa 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.
PubMed 17535234Moncrieff 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.
PubMed 11952545
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Expression and Function in Cutaneous Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00536029
- Acronym / sponsor ID
- H-C-2007-0009
- Conditions
- Melanoma
- Keywords
- Melanoma, SIAscope, pigmented skin lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Sep 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.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subject with pigmented skin lesion suspect for malignant melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pigmented lesion
Key exclusion criteria (1 listed)
- No pigmented lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
- Background: PubMed 17485052Govindan 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.
- Background: PubMed 17535234Haniffa 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.
- Background: PubMed 11952545Moncrieff 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.
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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.
Martin Glud, Cand.med. principal investigator
Department for Plastic Surgery and Burn Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Sep 2007. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536029, which also lists 3 linked publications.
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 27 Sep 2007.