Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients

Running, not enrolling · Not applicable

Conditions studied: Skin Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06539468

Run by

University of Michigan Rogel Cancer Center

People needed

81

Starts

2024-10-08

Expected to finish

2027-04-28

Last updated by the study team

2026-06-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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