Clinical trial NCT05473507: A Study of Observation and Follow-up in People With Basal Cell Carcinoma
Official title: Basal Cell Carcinoma Follow Up Study. A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Basal Cell Carcinoma
Keywords: Basal Cell Carcinoma
Memorial Sloan Kettering Cancer Center
21-007
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Change in Basal Cell Carcinoma growth from Baseline
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ashfaq Marghoob, MD
role: PRINCIPAL_INVESTIGATOR
References: