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

Conditions

• Skin Basal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Receive SOC treatment
• Educational Activity — OTHER
  Watch an educational video on AS for LR-BCC
• Patient Observation — OTHER
  Undergo active surveillance
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Oct 8, 2024

Status verified

Apr 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

Enrollment in part B (Part A) [ Time Frame: 6 months ]

Locations (1)

Find similar trials in Ann Arbor, MI

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