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Behavioural Intervention

Active Surveillance for Basal Cell Carcinoma

N/A

Recruiting

Led By Allison Billi

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Subject of any gender aged ≥ 65 years at the time of enrollment

Must not have

Individuals with a genetic syndrome predisposing to development of basal cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates if watching and not treating low-risk basal cell carcinoma in elderly patients is a safe and comfortable option when compared to standard treatments like surgery. Basal cell carcinoma is a slow-growing skin cancer

Who is the study for?

This trial is for elderly patients with low-risk basal cell carcinoma (LR-BCC), a type of skin cancer. It's specifically for those whose cancers are smaller than a nickel and located on the trunk or limbs. Patients must be comfortable with active surveillance, which means monitoring the cancer without immediate treatment.

What is being tested?

The study is testing if watching and waiting (active surveillance) is as safe and comfortable as standard treatments like surgery for small, low-risk skin cancers in elderly patients. Participants will not receive immediate treatment unless their cancer worsens.

What are the potential side effects?

Since this trial involves active surveillance rather than medication or invasive procedures, there may be few to no side effects directly from the trial approach itself. However, anxiety or stress related to not actively treating the cancer could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a low-risk basal cell carcinoma smaller than 2cm, not on my hands, feet, or face.

Select...

I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a genetic condition that increases my risk for basal cell carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment in part B (Part A)

Satisfaction with AS/standard of care (SOC) (Part B)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Part A (educational activity, survey administration)Experimental Treatment2 Interventions

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

Group II: Part B arm 1 (active surveillance)Active Control2 Interventions

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.

Group III: Part B arm 2 (SOC)Active Control2 Interventions

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.

0 / 3Eligibility criteria met