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

NCT06539468 | Recruiting DMC

• 3 other identifiers: UMCC 2023.115NCI-2024-05523HUM00243172
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Part A (educational activity, survey administration)

EXPERIMENTAL

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

Other: Educational Activity; Other: Survey Administration

Part B arm 1 (active surveillance)

ACTIVE COMPARATOR

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: Patient Observation; Other: Survey Administration

Part B arm 2 (SOC)

ACTIVE COMPARATOR

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: Best Practice; Other: Survey Administration

Interventions

Best Practice OTHER

Receive SOC treatment

Also known as: standard of care, standard therapy

Part B arm 2 (SOC)

Educational Activity OTHER

Watch an educational video on AS for LR-BCC

Part A (educational activity, survey administration)

Patient Observation OTHER

Undergo active surveillance

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Part B arm 1 (active surveillance)

Survey Administration OTHER

Ancillary studies

Part A (educational activity, survey administration); Part B arm 1 (active surveillance); Part B arm 2 (SOC)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Practice Guidelines as Topic; Standard of Care; Watchful Waiting; Observation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Methods; Investigative Techniques

Study Officials

• Allison Billi

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 6, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)