RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly

Quick Facts

Study Start:2024-10-08
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06539468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject of any gender aged ≥ 65 years at the time of enrollment
  2. * Patient at University of Michigan Department of Dermatology (UMichDD)
  3. * Willing and able to provide informed consent
  4. * Willing and able to comply with the protocol requirements
  5. * 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)
  1. * 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)
  2. * Individuals who expect to relocate and will be unable to return to UMichDD for clinical follow-up visit(s)
  3. * Individuals with a genetic syndrome predisposing to development of basal cell carcinoma

Contacts and Locations

Principal Investigator

Allison Billi
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Allison Billi, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2024-10-08
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Skin Basal Cell Carcinoma