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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Basal Cell Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Patient Observation; Other: Best Practice; Other: Educational Activity

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. (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 the hypothesis that active surveillance of biopsy-proven low-risk BCC is an acceptable alternative to standard treatment.

III. To collect pilot data on clinical outcomes of AS versus SOC for asymptomatic LR-BCC among the elderly for a duration of one year (the typical interval for skin cancer screening examinations for patients with a history of skin cancer).

IV. To compare the effects of AS vs. SOC for LR-BCC among the elderly on healthcare utilization.

V. To identify baseline characteristics that may predict a positive experience with AS.

VI. To explore perceived benefits of and concerns regarding participation in the RCT among the study population.

VII. To explore perceived benefits of and concerns regarding AS for LR-BCC among the study population.

VIII. To explore causes of nonadherence to maintenance of randomization in part B.

IX. To explore causes of nonadherence to follow-up in part B.

OUTLINE:

PART A: Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study.

PART B: Patients are randomized to 1 of 2 arms - as below and complete a standard 1-year follow-up total body skin examination followed by a second survey.

ARM 1: 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.

ARM 2: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Contact: Allison Billi; Phone Number: 734-936-4054; Email: acbilli@med.umich.edu
      • Principal Investigator: Allison Billi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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, nail units, and ankles (corresponding to area L in the Mohs Appropriate Use Criteria, representing the lowest risk areas)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Other: Educational Activity; Watch an educational video on AS for LR-BCC
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.	Other: Survey Administration; Ancillary studies; Other: Patient Observation; Undergo active surveillance; Other Names: Observation; Active Surveillance; deferred therapy; expectant management; Watchful Waiting
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.	Other: Survey Administration; Ancillary studies; Other: Best Practice; Receive SOC treatment; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment in part B (Part A)	Will evaluate the associations between baseline characteristics and the primary outcome of enrollment in part B (up to accrual target for 100 subjects) by logistic regression. Baseline characteristics include demographics, clinical data, patient-reported measures, baseline comfort with active surveillance (AS), and interest in enrollment in part B. The clinical research coordinator will assign each participant in part A a value of 1 if enrolled in part B or 0 if not enrolled (up to accrual target of 100 subjects for part B).	6 months
Satisfaction with AS/standard of care (SOC) (Part B)	Will compare the satisfaction of participants randomized to AS versus SOC as measured by five-point Likert scale.	At week 52

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Allison Billi, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Methods; Quality of Health Care; Quality Indicators, Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Observation; Watchful Waiting; Practice Guidelines as Topic
• Other Study ID Numbers: UMCC 2023.115 (University of Michigan Comprehensive Cancer Center); NCI-2024-05523 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00243172 (Other Identifier: University of Michigan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No