Non-melanoma Skin Cancer
Conditions
Keywords
dermoscopy, 3D total body photography, optical coherence tomography, in vivo reflectance confocal microscopy, total body photography, non-invasive imaging, confocal microscopy
Brief summary
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
Detailed description
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.
Interventions
DEVICEoptical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography
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
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
participant and investigator, who does the clinical examination and planning of surgery are not blinded, but surgeons and pathologists are blinded to the groups
Intervention model description
randomized, controlled, unicentric study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions
Exclusion criteria
* Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision * Patients younger than 18 years * Patients that are incapable of giving consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Management of non-melanoma skin cancer | up to 24 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer | up to 24 months | 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? |
| Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer | up to 24 months | 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? |
| Diagnostic accuracy of 3D total body photography | up to 24 months | Examination of diagnostic accuracy of 3D total body photography regarding non-melanoma skin cancer in comparison to examination with dermoscopy |
Countries
Germany
Outcome results
None listed