An interventional study of Best Practice and Educational Activity in Skin Basal Cell Carcinoma, sponsored by University of Michigan Rogel Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.
This study's enrollment of 81 is above the median of 41 across 258 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Receive SOC treatment
Also known as: standard of care, standard therapy
Watch an educational video on AS for LR-BCC
Undergo active surveillance
Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting
Ancillary studies
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).
Time frame: 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.
Time frame: At week 52
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center