RecruitingNCT06252857

Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma

Real-world Evaluation of (Non-invasive) Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma: a Prospective Cohort Study


Sponsor

Maastricht University Medical Center

Enrollment

142 participants

Start Date

Apr 22, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a cream called imiquimod (IMQ) can effectively treat a type of low-risk skin cancer called basal cell carcinoma (BCC) — the most common type of skin cancer. Researchers want to see how the cream performs in real-world practice and whether advanced imaging (called OCT, a type of non-invasive skin scan) can help diagnose and monitor treatment without requiring a biopsy. **You may be eligible if...** - You are 18 or older with a confirmed low-risk basal cell carcinoma - Your tumor meets specific criteria for low-risk classification - You can understand and follow the treatment instructions **You may NOT be eligible if...** - Your tumor is located on high-risk areas like the center of the face, scalp, or genital area - You have recurrent BCC or another skin cancer nearby - Your BCC is a more aggressive or high-risk subtype - You are pregnant or breastfeeding - You have an allergy to imiquimod - You are taking immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImiquimod Topical

Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision.


Locations(1)

Maastricht UMC+

Maastricht, Limburg, Netherlands

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NCT06252857


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