Active — Not RecruitingNot Applicable

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

United States26 participantsStarted 2022-07-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Basal Cell Carcinoma growth from Baseline

Timeframe: 3 years

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: up to 3 years

Trial details

NCT IDNCT05473507

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Basal Cell Carcinoma trials