Skin Basal Cell CarcinomaNCT06539468
Active Surveillance for the Treatment of Low-Risk Basal Cell Carcinoma in Elderly Patients
A study testing Best Practice, Educational Activity and Patient Observation in people with Skin Basal Cell Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Skin Basal Cell Carcinoma
- What is being tested?
- Best Practice, Educational Activity and Patient Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 28 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Skin Basal Cell Carcinoma
- Being tested
- Best Practice, Educational Activity, Patient Observation, Survey Administration
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC treatment
Educational ActivityOther
Watch an educational video on AS for LR-BCC
Patient ObservationOther
Also called Active Surveillance, deferred therapy, expectant management, Observation
Undergo active surveillance
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Part A (educational activity, survey administration) | Experimental | Patients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study. Receives: Other: Educational Activity; Other: Survey Administration |
| Part B arm 1 (active surveillance) | Active comparator | 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. Receives: Other: Patient Observation; Other: Survey Administration |
| Part B arm 2 (SOC) | Active comparator | 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. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start8 Oct 2024
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Billi, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539468
- Sponsor's protocol ID
- UMCC 2023.115
- Other IDs
- NCI-2024-05523, HUM00243172
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Active Surveillance for Management of Low-Risk Basal Cell Carcinoma in the Elderly
- ClinicalTrials.gov ID
- NCT06539468
- Acronym / sponsor ID
- UMCC 2023.115
- Conditions
- Skin Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A (educational activity, survey administration) | Experimental | Other: Educational Activity, Other: Survey AdministrationPatients watch an educational video on AS for LR-BCC and complete a survey about comfort with AS for LR-BCC on study. |
| Part B arm 1 (active surveillance) | Active comparator | Other: Patient Observation, Other: Survey AdministrationPatients 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. |
| Part B arm 2 (SOC) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC treatment | Other | Part B arm 2 (SOC) |
| Educational ActivityWatch an educational video on AS for LR-BCC | Other | Part A (educational activity, survey administration) |
| Patient ObservationAlso: Active Surveillance, deferred therapy, expectant management, ObservationUndergo active surveillance | Other | Part B arm 1 (active surveillance) |
| Survey AdministrationAncillary studies | Other | Part A (educational activity, survey administration), Part B arm 1 (active surveillance), Part B arm 2 (SOC) |
Primary outcome
Enrollment in part B (Part A)
Time frame: 6 months
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).
Satisfaction with AS/standard of care (SOC) (Part B)
Time frame: At week 52
Will compare the satisfaction of participants randomized to AS versus SOC as measured by five-point Likert scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Billi principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Activity and Patient Observation in people with Skin Basal Cell Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in part B (Part A) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.