Active Surveillance for Basal Cell Carcinoma

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Immunosuppressive medications

Disqualifiers: Immunocompromised, Relocation, Genetic syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether monitoring low-risk basal cell carcinoma, a slow-growing skin cancer, is a safe and comfortable alternative to standard treatments. Typically, treatment involves procedures like surgery, which can cause side effects. The trial compares this watchful waiting approach, also known as active surveillance, to standard treatments to determine its viability for patients. It is open to individuals aged 65 and older diagnosed with low-risk basal cell carcinoma on their trunk or limbs and who are patients at the University of Michigan Department of Dermatology. As an unphased trial, this study allows patients to contribute to innovative research that could lead to more comfortable treatment options.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications like prednisone > 10 mg daily, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medications like prednisone over 10 mg daily, you may not be eligible to participate.

What prior data suggests that active surveillance is safe for managing low-risk basal cell carcinoma?

Research has shown that active surveillance, which involves monitoring the cancer and treating it only if it worsens, generally provides a safe way to manage low-risk basal cell carcinoma (LR-BCC). This method suits older adults with small, slow-growing skin cancers. Studies have found it to be a comfortable alternative to standard treatments, which often carry risks such as bleeding and infection after surgery. Although doctors sometimes hesitate to recommend active surveillance due to a lack of direct comparison with standard care, evidence supports its safety for LR-BCC patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about active surveillance for basal cell carcinoma (BCC) because it offers a less invasive approach compared to standard treatments like surgical resection or Mohs surgery. Active surveillance involves closely monitoring the condition without immediate intervention, which can reduce unnecessary procedures and associated side effects. This approach is particularly appealing for patients with low-risk BCC, as it prioritizes comfort and quality of life while still ensuring that any disease progression is caught early.

What evidence suggests that active surveillance is a safe and comfortable alternative for low-risk basal cell carcinoma?

Research shows that monitoring low-risk basal cell carcinoma (LR-BCC) can be a safe choice. In this trial, participants in the active surveillance arm will receive no immediate treatment and will undergo regular monitoring over one year. Studies have found that most patients do not develop new symptoms when they choose to monitor their condition. Even when treatment is delayed, more intense procedures are rarely needed. This suggests that simply watching and waiting might be a good option for some patients without needing immediate treatment. However, active surveillance involves regularly checking the condition rather than treating it right away, so regular check-ups are important. Overall, this approach can comfortably manage LR-BCC, especially for older adults. ^{1 3 5 6 7}

Who Is on the Research Team?

Allison Billi

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Willing and able to provide informed consent

Willing and able to comply with the protocol requirements

Exclusion Criteria

Individuals who expect to relocate and will be unable to return to UMichDD for clinical follow-up visit(s)

I am considered immunocompromised due to medication, HIV, or an organ transplant.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Activity and Survey

Participants watch an educational video on active surveillance for low-risk basal cell carcinoma and complete a survey about their comfort with this approach.

1 visit

1 visit (in-person or virtual)

Active Surveillance or Standard of Care Treatment

Participants are randomized to either active surveillance with no treatment unless disease progression occurs, or standard of care treatment which may include electrodesiccation and curettage, surgical resection, or Mohs surgery.

1 year

Regular monitoring visits as needed

Follow-up

Participants complete a standard 1-year follow-up total body skin examination followed by a second survey to assess satisfaction and outcomes.

1 year

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active Surveillance

Trial Overview 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.

How Is the Trial Designed?

Group I: Part A (educational activity, survey administration) Experimental Treatment 2 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 Control 2 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 Control 2 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.

Active Surveillance is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Active Surveillance for:

• Papillary thyroid microcarcinoma (PTMC)

Approved in European Union as Active Surveillance for:

• Papillary thyroid microcarcinoma (PTMC)

Approved in Canada as Active Surveillance for:

• Papillary thyroid microcarcinoma (PTMC)

Approved in Japan as Active Surveillance for:

• Papillary thyroid microcarcinoma (PTMC)

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

In a 10-year study of basal cell carcinoma (BCC), only 53 tumors were found in the groin or buttocks, representing a very rare occurrence (0.094% of all BCCs), with the most common subtype being nodular (49%).

The study found that these BCCs in nonexposed areas were not associated with genetic predispositions or immunosuppression, and their histological characteristics were not more aggressive than BCCs found in other body locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basal cell carcinoma of the groin and buttocks: a clinical and histological analysis of a rare presentation of a common tumor. Tidwell, WJ., Sutton, A., Gilbertson, R., et al.[2019]

Basal cell carcinomas (BCCs) are the most common skin cancers in fair-skinned adults over 50, primarily caused by UV exposure, and their management has been updated in recent guidelines to address varying prognoses and treatment options.

For difficult-to-treat BCCs, hedgehog pathway inhibitors have been developed, and ongoing trials suggest that immunotherapy may be an option for tumors resistant to these inhibitors, highlighting the importance of personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update in the Management of Basal Cell Carcinoma. Basset-Seguin, N., Herms, F.[2022]

In a study of 34 patients with basal cell carcinoma (BCC) that had positive surgical margins, EGFR expression was found to be significantly higher in tumor tissues compared to healthy tissues, indicating its potential role in tumor behavior.

Patients with recurrent BCC lesions exhibited EGFR expression levels that were 6.66 times higher than those without recurrence, suggesting that EGFR overexpression may be linked to increased recurrence rates, particularly in infiltrative subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of EGFR overexpression on the recurrence of basal cell carcinomas with positive surgical margins. Biray Avci, C., Kaya, I., Ozturk, A., et al.[2019]

Basal cell carcinoma (BCC) is the most common skin cancer, primarily affecting light-skinned individuals, with risk factors including UV exposure and genetic mutations in the hedgehog pathway.

Most BCC cases can be effectively treated with standard surgery or topical treatments, while advanced cases may require radiation or systemic therapies, including hedgehog inhibitors like vismodegib and sonidegib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Known and new facts on basal cell carcinoma. Seidl-Philipp, M., Frischhut, N., Höllweger, N., et al.[2021]

From 2001 to 2019, over 601,000 patients were diagnosed with basal cell carcinoma (BCC) in the Netherlands, with age-standardized incidence rates for first BCCs significantly increasing for both men and women, indicating a growing public health concern.

While younger patients (under 50) show signs of stabilizing incidence rates, older patients (50 and above) continue to experience rising rates, with predictions suggesting a further increase of over 30% in BCC cases in the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nationwide study of the incidence and trends of first and multiple basal cell carcinomas in the Netherlands and prediction of future incidence. Schreuder, K., Hollestein, L., Nijsten, TEC., et al.[2022]

In a study of 89 patients with basal cell carcinoma (BCC) who chose watchful waiting (WW) for a median follow-up of 9 months, the majority (83%) opted for this approach due to personal factors like frailty or limited life expectancy, indicating that WW can be a suitable option for certain patients.

Only 47% of the tumors increased in size during the observation period, with tumor growth linked to specific BCC subtypes, suggesting that many patients may safely delay treatment without significant risk of rapid tumor progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Watchful Waiting and Tumor Behavior in Patients With Basal Cell Carcinoma: An Observational Cohort Study of 280 Basal Cell Carcinomas in 89 Patients. van Winden, MEC., Hetterschijt, CRM., Bronkhorst, EM., et al.[2022]

Surgery, particularly micrographically controlled surgery, remains the gold standard for treating basal cell carcinoma, while non-invasive methods and histological confirmation are important for accurate diagnosis and risk stratification.

For advanced or metastatic cases, effective treatments like hedgehog inhibitors and the PD-1 inhibitor cemiplimab are available, alongside preventive measures such as UV protection and oral medications like nicotinamide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current Management of Basal Cell Carcinoma]. Krieter, M., Schultz, E.[2023]

A study of 14,628 participants identified that 293 individuals developed a second basal cell carcinoma (BCC) within a median of 3 years, highlighting the significant risk of recurrence after an initial BCC diagnosis.

The developed prediction model, which uses 13 clinical characteristics, can categorize patients into three risk groups (7%, 12%, and 28% risk of a second BCC within 3 years), helping to identify those at higher risk for better monitoring and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the Risk of a Second Basal Cell Carcinoma. Verkouteren, JAC., Smedinga, H., Steyerberg, EW., et al.[2018]

In a study of 1,832 basal cell carcinomas excised from 1,329 patients over six years, 14% of the lesions were found to be incompletely excised, highlighting a significant challenge in surgical treatment.

The study identified that the location of the tumor, particularly those on the nose, was a key predictor of incomplete excision, suggesting that surgical techniques may need to be adjusted based on tumor location to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and outcome analysis of 1832 consecutively excised basal cell carcinomas in a tertiary referral plastic surgery unit. Malik, V., Goh, KS., Leong, S., et al.[2010]

A retrospective study in Dorset, UK, revealed a significant increase in basal cell carcinoma (BCC) cases, with 2455 patients in 2006 rising to 3797 in 2016, indicating a higher incidence rate than previously reported in the UK.

The most common sites for BCC were found to be on the head and neck, particularly the cheek, nose, and forehead, highlighting the need for improved monitoring and preventive strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of basal cell carcinoma: a 10-year comparative study. Devine, C., Srinivasan, B., Sayan, A., et al.[2022]

The study found that mutations in the PTCH gene, particularly those associated with UV exposure, are common in basal cell carcinoma (BCC) patients, occurring in 48% of cases, but these mutations do not vary significantly among different age groups or lesion counts.

Certain single-nucleotide polymorphisms (SNPs) in the PTCH gene, specifically IVS16-80G/C and IVS17+21G/A, may play a role in tumorigenesis for some BCC patients, although their distribution did not differ significantly across early-onset and regular BCC cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UV fingerprints predominate in the PTCH mutation spectra of basal cell carcinomas independent of clinical phenotype. Heitzer, E., Lassacher, A., Quehenberger, F., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9075932/

Active Surveillance as a Management Option for Low-risk ... We propose that active surveillance be evaluated as a management option for select patients with low-risk and asymptomatic basal cell carcinoma.

2. withpower.com withpower.com/trial/phase-carcinoma-basal-cell-7-2024-4b00e

Active Surveillance for Basal Cell Carcinoma The available research does not provide specific data supporting Active Surveillance as an effective treatment for Basal Cell Carcinoma. Instead, it highlights ...

3. mdedge.com mdedge.com/hematology-oncology/article/247464/nonmelanoma-skin-cancer/watchful-waiting-sometimes-best

Watchful waiting sometimes best for asymptomatic basal ... The study “shows that few patients developed new symptoms, and few patients who decided to treat after a delay had more invasive interventions ...

4. researchgate.net researchgate.net/publication/354453343_Evaluation_of_Watchful_Waiting_and_Tumor_Behavior_in_Patients_With_Basal_Cell_Carcinoma_An_Observational_Cohort_Study_of_280_Basal_Cell_Carcinomas_in_89_Patients

Evaluation of Watchful Waiting and Tumor Behavior in ... Results Watchful waiting was chosen for 280 BCCs in 89 patients (47 men [53%] and 42 women [47%]), with a median (interquartile range [IQR]) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34495284/

Evaluation of Watchful Waiting and Tumor Behavior in ... Results: Watchful waiting was chosen for 280 BCCs in 89 patients (47 men [53%] and 42 women [47%]), with a median (interquartile range [IQR]) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06539468

Active Surveillance for the Treatment of Low-Risk Basal ... These treatments can carry risks like post-operative bleeding and wound infection, and they do not always improve tumor-related quality of life.

7. researchgate.net researchgate.net/publication/352390681_Active_Surveillance_as_a_Management_Option_for_Low-risk_Basal_Cell_Carcinoma

Active Surveillance as a Management Option for Low-risk ... There were 327 higher risk BCCs in 128 OTRs, more per person than in the general population with 703 in 457 cases (chi-square p = 0.008). ... ..