Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Michigan
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2025-12-28
Participants
Target number of participants: 200
Treatments
Experimental: Part A (educational activity, survey administration)
Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study.
Active_comparator: Part B arm 1 (active surveillance)
Patients receive no treatment and undergo active surveillance over 1 year in the absence of disease progression. Patients may choose to undergo treatment at any point on study. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
Active_comparator: Part B arm 2 (SOC)
Patients receive SOC treatment which typically includes either electrodesiccation and curettage, surgical resection, or Mohs surgery as agreed upon by patient and provider in the absence of disease progression. Patients complete a standard 1-year follow-up total body skin examination followed by a second survey.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center

This content was sourced from clinicaltrials.gov