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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Basal Cell Carcinoma

Treatments: Diagnostic Test: Total Skin Examinations; Diagnostic Test: Dermtech tape-stripping; Diagnostic Test: Reflectance confocal microscopy (RCM); Diagnostic Test: Digital Dermoscopy; Diagnostic Test: Optical coherence tomography (OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT05473507

21-007

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Participant with Basal Cell Carcinoma/BCC

Description:

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)

Treatment:

Diagnostic Test: Dermtech tape-stripping

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Digital Dermoscopy

Diagnostic Test: Reflectance confocal microscopy (RCM)

Diagnostic Test: Total Skin Examinations