Evaluating non-invasive and invasive treatments for 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
Maastricht University Medical Center · NCT06252857
This study is testing different ways to treat low-risk basal cell carcinoma, including non-invasive methods and surgery, to see which works best in real-life situations for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center (other) |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06252857 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness of various diagnostic and treatment strategies for low-risk basal cell carcinoma (BCC), focusing on both non-invasive methods like Optical Coherence Tomography (OCT) and topical treatments such as imiquimod, as well as traditional surgical excision. By including patients diagnosed with low-risk BCC, the study will gather data on the outcomes of these management strategies in everyday clinical practice. The goal is to enhance understanding of how these approaches perform in real-world settings, potentially influencing future treatment guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with low-risk basal cell carcinoma confirmed by OCT or histopathology.
Not a fit: Patients with recurrent basal cell carcinoma, high-risk subtypes, or those with specific tumor locations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective non-invasive treatment options for low-risk basal cell carcinoma, improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown promise in using non-invasive diagnostic and treatment methods for basal cell carcinoma, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥18 years old * Diagnosis of low-risk BCC based on CDE with OCT confirmation or with histopathological verification in case OCT diagnosis is doubtful. * Tumors meeting the criteria for low-risk BCC * Patient is able to understand the instruction regarding the study participation and application of IMQ treatment Exclusion Criteria: * Tumor location in the H-zone of the face or hairy scalp, anogenital area * Diagnosis of recurrent BCC or previous skin cancer within 2cm of the treatment area * Strong suspicion/diagnosis of high-risk BCC subtype or other skin condition on OCT or punch biopsy * Women who are pregnant or breastfeeding * Previous allergy or intolerance to IMQ * No concurrent use any other systemic chemopreventive or immunosuppressive medication during the treatment period, 30 days before start and 3 months after the end of treatment * Limited understanding of the Dutch language and not being able to give informed consent
Where this trial is running
Maastricht, Limburg
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Myrthe MG Moermans, MD
- Email: myrthe.moermans@mumc.nl
- Phone: +31433877295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Basal Cell Carcinoma, imiquimod, surgical excision