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

NCT ID: NCT06539468

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-12-28

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). 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.

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.

Conditions

Skin Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Activity

Intervention Type: OTHER

Watch an educational video on AS for LR-BCC

Survey Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

Patient Observation

Intervention Type: OTHER

Undergo active surveillance

Survey Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive SOC treatment

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive SOC treatment

Intervention Type: OTHER

Educational Activity

Watch an educational video on AS for LR-BCC

Intervention Type: OTHER

Patient Observation

Undergo active surveillance

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Active Surveillance; deferred therapy; expectant management; Observation; Watchful Waiting

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Billi

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Allison Billi

Role: primary

acbilli@med.umich.edu

734-936-4054

Other Identifiers

NCI-2024-05523

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUM00243172

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2023.115

Identifier Type: -

Identifier Source: org_study_id