Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
NCT06539468
Summary
This clinical trial evaluates whether active surveillance (AS) is a safe and comfortable alternative to standard of care (SOC) treatment for elderly patients with low-risk basal cell carcinoma (LR-BCC). Basal cell carcinoma is a type of slow-growing skin cancer that has a very low risk of spreading inside the body (metastasis) or death. Basal cell skin cancers that are smaller across than a nickel in size and located on the trunk or limbs are particularly low risk to overall health. Active surveillance - watching and not treating unless the cancer worsens - has been shown to be a generally safe way to manage LR-BCC. Despite this, many doctors do not feel comfortable discussing this option with patients due to a lack of studies comparing it to standard of care treatment. Standard of care treatment for LR-BCC can include "scrape and burn" (electrodesiccation and curettage), surgical resection, Mohs surgery, and other approaches. These treatments can carry risks like post-operative bleeding and wound infection, and they do not always improve tumor-related quality of life. Active surveillance may be a safe and comfortable alternative to SOC treatment for elderly patients with LR-BCC.
Eligibility
Inclusion Criteria: * Subject of any gender aged ≥ 65 years at the time of enrollment * Patient at University of Michigan Department of Dermatology (UMichDD) * Willing and able to provide informed consent * Willing and able to comply with the protocol requirements * Histopathologic diagnosis of one or more LR-BCC(s) within 2 months of enrollment. LR-BCC is defined here as biopsy proven primary (not recurrent) BCC of any morphologic subtype; \< 2cm in size; with or without marginal involvement on histopathology; and located on the trunk or extremities excluding pretibial surface, hands, feet, nail units, and ankles (corresponding to area L in the Mohs Appropriate Use Criteria, representing the lowest risk areas) Exclusion Criteria: * Individuals who are immunocompromised per judgement of investigator (examples include but are not limited to patients on immunosuppressive medications such as prednisone \> 10 mg daily, uncontrolled HIV, and organ transplant recipients on immunosuppressive therapy) * Individuals who expect to relocate and will be unable to return to UMichDD for clinical follow-up visit(s) * Individuals with a genetic syndrome predisposing to development of basal cell carcinoma
Conditions2
Locations1 site
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NCT06539468