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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant with Basal Cell Carcinoma/BCC | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Dermoscopy | Diagnostic Test | Digital Dermoscopy will be performed every 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Basal Cell Carcinoma growth from Baseline | 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. | 3 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To evaluate the feasibility of active follow-up of BCC as a way of managing BCC. | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with at least 1 BCC eligible for the study will be recruited from the Memorial Sloan Kettering Dermatology sites at the Manhattan and Hauppauge clinics. Only 1 of the participant's BCCs will be selected for inclusion in the study. All patients 18 years of age or older who have been diagnosed with BCC will be eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Ashfaq Marghoob, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| Reflectance confocal microscopy (RCM) | Diagnostic Test | Reflectance confocal microscopy (RCM) will be performed every 3 months. |
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| Optical coherence tomography (OCT) | Diagnostic Test | Optical coherence tomography (OCT) will be performed every 3 months. |
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| Dermtech tape-stripping | Diagnostic Test | Dermtech tape-stripping for genetic analysiswill be performed every 6 months. |
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| Total Skin Examinations | Diagnostic Test | Total Skin Examinations will be performed every 12 months. |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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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 |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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