Observing and following up on patients with Basal Cell Carcinoma
Basal Cell Carcinoma Follow Up Study. A Prospective Study
This study is looking to track how Basal Cell Carcinomas grow over time to find better ways to monitor and treat these skin cancers, but it won't provide any treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05473507 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the growth patterns of Basal Cell Carcinomas (BCCs) and to explore more effective monitoring and treatment strategies for these common skin cancers. Participants will undergo various non-invasive imaging techniques, including digital dermoscopy and optical coherence tomography, over a three-year period. The study will not provide any treatment but will focus on understanding the natural progression of BCCs in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with at least one treatment-naive BCC that meets specific size and depth criteria.
Not a fit: Patients who are immunosuppressed or have genetic syndromes that increase the risk of BCC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with Basal Cell Carcinoma.
How similar studies have performed: While observational studies on skin cancers exist, this specific approach focusing on BCCs and utilizing advanced imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ashfaq Marghoob, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Ashfaq Marghoob, MD
- Email: marghooa@mskcc.org
- Phone: 631-863-5116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.