Melanoma (Skin) Clinical Trial
Official title:
Reflectance Confocal Microscopy to Diagnose Malignant Melanoma and Lentigo Maligna
NCT number | NCT03508297 |
Other study ID # | HS-MAV-002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 14, 2017 |
Est. completion date | August 31, 2020 |
Verified date | November 2021 |
Source | Skin Care Network Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).
Status | Completed |
Enrollment | 597 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years or older 2. Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM. 3. Patient willing and able to give informed consent Exclusion Criteria: 1. Recurrent MM or LM 2. Patient on immunosuppresants 3. Patient with significant co-morbidity or skin disease 4. Patient not suitable for diagnostic biopsy 5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Skin Care Network Barnet Ltd | London |
Lead Sponsor | Collaborator |
---|---|
Skin Care Network Ltd. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number Needed to Excise | The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion | During exam (biopsy results typically available within one week). | |
Secondary | intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater | A measure of how consistently readers can diagnose from confocal images. | 6 months |
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