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Basal cell carcinoma (BCC) is the most prevalent form of cancer among the Caucasian population. There are several subtypes of BCC with different clinical characteristics and treatment strategies. Superficial and nodular BCCs are low-risk BCC subtypes. The diagnosis and subtype of BCC can be confirmed by means of punch biopsy, but non-invasive diagnosis by means of Optical Coherence Tomography (OCT) is proven to be a non-inferior alternative diagnostic instrument. Besides, non-invasive topical treatment is recommended as valuable treatment alternative to surgical excision for low-risk BCC.
Since non-invasive diagnosis and treatment for low-risk BCC is being implemented into daily practice, we want to evaluate the real-world effectiveness of different invasive and non-invasive diagnostic and treatment strategies in the management of low-risk BCC. This real-world evidence will enhance our understanding of these management strategies for low-risk BCC in daily practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod Topical | Drug | Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of imiquimod versus surgical excision | Treatment success, expressed as the proportion of tumor free patients | 1 year post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Incidence and severity of adverse effects | During imiquimod treatment, reported by the patient |
| Mean treatment compliance for patients in the imiquimod group | In percentages |
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Inclusion Criteria:
Exclusion Criteria:
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Patients visiting the outpatient department of MUMC+ with a clinical suspicion for low-risk BCC, who have a final diagnosis of low-risk BCC confirmed by OCT, or by punch biopsy in case uncertainty about diagnosis remains after OCT. Patients will be treated in accordance with standard care: either SE or IMQ. The choice for treatment is based on shared decision making.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myrthe MG Moermans, MD | Contact | +31433877295 | myrthe.moermans@mumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC+ | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
IPD may be shared upon reasonable request
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| During treatment, reported by the patient in a treatment checklist |
| Cosmetic outcome | Patient-reported satisfaction with cosmetic result of treatment area, expressed as mean score on the DASS questionnaire | 1 year post-treatment |
| Patient treatment satisfaction | Patient-reported satisfaction with treatment, expressed as the proportion of patients reporting to be satisfied with their treatment on a 4-point Likert-scale. | 1 year post-treatment |
| Cost-effectiveness analysis | Cost-effectiveness will be analysed from a health-care perspective: pre-, during and post-treatment costs will be recorded and analysed and compared in both treatment groups using a cost-effectiveness analysis (CEA) | 1 year post-treatment |
| D018295 |
| Neoplasms, Basal Cell |
| D006571 | Heterocyclic Compounds |