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Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors
250 patients with lesions that are suspicious for non-melanoma skin cancer that had not yet had a biopsy, are randomized in 2 groups. The intervention group is examined with total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy; the control group is examined with dermoscopy only. The aim of the study is to investigate whether these methods improve the early detection of non-melanoma skin cancer and their precursors. Examined are not only the differences in management of the lesions (excision, biopsy, local treatment or no treatment) and the diagnostic accuracy of the devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy, optical coherence tomography, in vivo reflectance confocal microscopy and each patient gets 3D total body photography. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups. |
|
| Control group | No Intervention | After clinical examination, each lesion that is suspicious for non-melanoma skin cancer and/or its precursor, is examined with dermoscopy as is the standard of care. Afterwards, decision for management of each lesion is made (excision, biopsy, local treatment or no treatment). Surgeons are blinded to the groups but get the planning of surgery of the investigator. Pathologists are blinded to the groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography | Device | each lesion is in addition to examination with dermoscopy examined with optical coherence tomography, in vivo reflectance confocal microscopy, each patient is photographed with 3D total body photography |
| Measure | Description | Time Frame |
|---|---|---|
| Management of non-melanoma skin cancer | Is management of non-melanoma skin cancer optimized after using non-invasive imaging devices like optical coherence tomography, in vivo reflectance confocal microscopy in comparison to examination with dermoscopy alone (number of primary excisions, number of biopsies, number of secondary inpatient stays due to positive biopsies, number of local treatments and lesions in which no treatment is necessary) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer | Comparison of diagnostic accuracy of dermoscopy and optical coherence tomography and invivo reflectance confocal microscopy (is diagnostic accuracy of optical coherence tomography better or confocal microscopy better than in dermoscopy alone? |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden | Dresden | Saxony | 01307 | Germany |
The data that support the findings of this study are available on request from the principal investigator. The data are not publicly available due to privacy or ethical restrictions.
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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randomized, controlled, unicentric study
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participant and investigator, who does the clinical examination and planning of surgery are not blinded, but surgeons and pathologists are blinded to the groups
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| up to 24 months |
| Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer | Does the combination of the results of optical coherence tomography and in vivo reflectance confocal microscopy in each lesion lead to an even better diagnostic accuracy than each device alone? | up to 24 months |
| Diagnostic accuracy of 3D total body photography | Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy | up to 24 months |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |