RecruitingNot ApplicableNCT06539468

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

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


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

200 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

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


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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NCT06539468


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