A Study of Observation and Follow-up in People With Basal Cell Carcinoma
Basal Cell Carcinoma Follow Up Study. A Prospective Study
1 other identifier
observational
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
July 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
October 9, 2025
October 1, 2025
3.9 years
July 15, 2022
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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)
Interventions
Digital Dermoscopy will be performed every 3 months.
Reflectance confocal microscopy (RCM) will be performed every 3 months.
Optical coherence tomography (OCT) will be performed every 3 months.
Dermtech tape-stripping for genetic analysiswill be performed every 6 months.
Total Skin Examinations will be performed every 12 months.
Eligibility Criteria
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.
You may qualify if:
- Patients 18 years of age or older
- Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
- Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
- Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
- Treatment naiive lesions
- Ability to sign informed consent
You may not qualify if:
- Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
- Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
- Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
- Patients with BCCs that have a diameter larger than 1.5cm\\
- Patients with BCCs that have a depth greater than 0.6mm
- Patients with BCCs in high risk locations, i.e. "H" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers).
- Patients with BCCs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid).
- Tumor located on a site that precludes attachment of the RCM device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes)
- Lesions that previously received therapeutic intervention
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashfaq Marghoob, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2022
First Posted
July 26, 2022
Study Start
July 27, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.