Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients (NCT06539468) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
United States81 participantsStarted 2024-10-08
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Enrollment in part B (Part A)
Timeframe: 6 months
2
Satisfaction with AS/standard of care (SOC) (Part B)