Status:
RECRUITING
Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Skin Basal Cell Carcinoma
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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...
Detailed 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06539468
Start Date
October 8 2024
End Date
December 28 2025
Last Update
April 2 2025
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109