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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01152 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00018408 | Other Identifier | OHSU Knight Cancer Institute |
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The study did not meet its accrual goals due to the departure of study personnel. Study team opted for a study closure due to loss of key personnel.
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.
PRIMARY OBJECTIVE:
I. To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology.
SECONDARY OBJECTIVE:
I. To incorporate in vivo confocal images into the triage system in order to determine to what degree the information gathered in this modality changes the classification of a lesion assigned by a licensed dermatologist.
TERTIARY OBJECTIVE:
I. To assess the potential improvement of virtual patient triage when adding digital dermoscopy images to clinical images presented by patients to their provider (via e-visit or e-consult).
OUTLINE:
Participants undergo imaging of suspicious moles via smartphone application (app) MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine subcutaneously (SC) and undergo shave or punch biopsy of suspected melanomas.
After completion of study intervention, patients are followed up within 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (imaging, biopsy) | Experimental | Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal Microscopy | Other | Undergo confocal microscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the imaging modalities | Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals. | Up to 1 year |
| Specificity of imaging modalities | Specificity is defined as green (follow-up at annual skin exam) or yellow lesions (recommend examination by dermatologist in 3 months) correctly identified. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report | Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the VisioMed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home | Up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Ludzik, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sancy Leachman | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009508 | Nevus, Pigmented |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D018613 | Microscopy, Confocal |
| D046169 | Dermoscopy |
| D014965 | X-Rays |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Dermoscopy | Other | Undergo digital dermoscopy |
|
| Imaging Procedure | Procedure | Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone |
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| Lidocaine | Drug | Given SC |
|
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| Punch Biopsy | Procedure | Undergo punch biopsy |
|
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| Shave Biopsy | Procedure | Undergo shave biopsy |
|
| Up to 1 year |
| Specificity by changes after consideration of RCM report | Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the Visiomed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined. | Up to 1 year |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009506 | Nevus |
| D008919 |
| Investigative Techniques |
| D000069416 | Intravital Microscopy |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |