Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
University of Michigan Rogel Cancer Center
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.
Description
PRIMARY OBJECTIVES: I. To identify the baseline characteristics of patients who are willing and able to enroll in an randomized controlled trial (RCT) examining acceptability of AS versus (vs.) SOC. (Part A) II. To determine if satisfaction of patients randomized to AS is noninferior to satisfaction of those randomized to SOC at one-year follow-up. (Part B) EXPLORATORY OBJECTIVES: I. To collect additional pilot data on acceptability of AS for asymptomatic LR-BCC among the elderly. II. To determine the feasibility and optimal design of a future fully powered multi-institution RCT examining…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- OtherBest Practice
Receive SOC treatment
- OtherEducational Activity
Watch an educational video on AS for LR-BCC
- OtherPatient Observation
Undergo active surveillance
- OtherSurvey Administration
Ancillary studies
Location
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan