Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Skin Diseases

Acquire skin images with a new digital dermatoscope

Digital dermoscopy

A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.

Development and Validation of a New Digital Dermatoscope in the United States

The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree.

The outcome will be measured by a questionnaire with usability-related questions for clinicians.

The number of adverse events will be reported to assess safety of the device.

The outcome of the secondary objective will be an anonymized database of digital skin lesion images and corresponding metadata and a set of high quality images amenable to clinician evaluation.

Barco NV

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)

Digital Dermoscopy will be performed every 3 months.

Digital Dermoscopy

Reflectance confocal microscopy (RCM) will be performed every 3 months.

Reflectance confocal microscopy (RCM)

Optical coherence tomography (OCT) will be performed every 3 months.

Optical coherence tomography (OCT)

Dermtech tape-stripping for genetic analysiswill be performed every 6 months.

Dermtech tape-stripping

Total Skin Examinations will be performed every 12 months.

Total Skin Examinations

Ashfaq Marghoob, MD

Allan Halpern, MD

The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.

A Study of Observation and Follow-up in People With Basal Cell Carcinoma

Basal Cell Carcinoma Follow Up Study. A Prospective Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

To adequately measure the growth dynamics of tumors, several imaging modalities will be employed. Longest dimension (millimeters) of the lesion from clinical imaging will be the primary measurement of horizontal extent of the lesion. Maximum lesion depth (millimeters) from OCT imaging will be the primary measured of vertical extension.

To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development and Validation of a New Digital Dermatoscope in the United States	NCT04047316	Skin Cancer	Digital dermosc...	-	Barco NV
Development and Validation of a New Digital Dermatoscope in the United States	NCT04047316	Skin Cancer	Digital dermosc...	-	Barco NV
A Study of Observation and Follow-up in People With Basal Cell Carcinoma	NCT05473507	Basal Cell Carc...	Digital Dermosc... Reflectance con... Optical coheren... Dermtech tape-s... Total Skin Exam...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for digital dermoscopy