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

Recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Diagnostic Test: Digital Dermoscopy; Diagnostic Test: Reflectance confocal microscopy (RCM); Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Dermtech tape-stripping; Diagnostic Test: Total Skin Examinations

• Registration Number: NCT05473507
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-26
• Study Start: 2022-07-27
• Status Verified: 2024-12
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participant with Basal Cell Carcinoma/BCC	Optical coherence tomography (OCT)	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)
Participant with Basal Cell Carcinoma/BCC	Total Skin Examinations	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)
Participant with Basal Cell Carcinoma/BCC	Digital Dermoscopy	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)
Participant with Basal Cell Carcinoma/BCC	Reflectance confocal microscopy (RCM)	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)
Participant with Basal Cell Carcinoma/BCC	Dermtech tape-stripping	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)

Primary Outcome Measures

Name	Time	Method
Change in Basal Cell Carcinoma growth from Baseline	3 years	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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 3 years	To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States