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

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Description

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.

Targeted Conditions

Study Overview

Start Date
July 27, 2022
Completion Date
July 1, 2025
Enrollment
33
Date Posted
July 26, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065, United States

Eligibility

Study Population
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.
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Study Contact Info

Study Contact Name
Ashfaq Marghoob, MD; Allan Halpern, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05473507