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

Basal Cell Carcinoma Clinical Trial

Official title:

Basal Cell Carcinoma Follow Up Study. A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473507
• Other study ID #: 21-007
• Status: Recruiting
• Start date: July 27, 2022
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Ashfaq Marghoob, MD
• Phone: 631-863-5116
• Email: marghooa[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Diagnostic Test:
• Digital Dermoscopy
Digital Dermoscopy will be performed every 3 months.
• Reflectance confocal microscopy (RCM)
Reflectance confocal microscopy (RCM) will be performed every 3 months.
• Optical coherence tomography (OCT)
Optical coherence tomography (OCT) will be performed every 3 months.
• Dermtech tape-stripping
Dermtech tape-stripping for genetic analysiswill be performed every 6 months.
• Total Skin Examinations
Total Skin Examinations will be performed every 12 months.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center