Evaluating oral hedgehog inhibitors for treating basal cell carcinoma in the Netherlands
Registration of Oral Hedgehog Inhibitors Vismodegib and Sonidegib in the Treatment of Advanced and Multiple Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study.
This study is testing if two oral medications, vismodegib and sonidegib, can help people with advanced basal cell carcinoma or Gorlin syndrome feel better and improve their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 8 sites (Nijmegen, Gelderland and 7 other locations) |
| Trial ID | NCT05463757 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of oral hedgehog inhibitors, vismodegib and sonidegib, in patients with locally advanced and metastatic basal cell carcinoma, as well as those with Gorlin syndrome. Conducted across eight academic hospitals in the Netherlands, it collects comprehensive data on patient demographics, tumor characteristics, treatment details, and outcomes. The study will also compare the two medications to determine their relative effectiveness. All patients receiving these treatments will be included, provided they consent to participate.
Who should consider this trial
Good fit: Ideal candidates include men and women of all ages diagnosed with locally advanced or metastatic basal cell carcinoma or Gorlin syndrome who are prescribed vismodegib or sonidegib.
Not a fit: Patients who do not have basal cell carcinoma or Gorlin syndrome, or those not receiving treatment with the specified oral hedgehog inhibitors, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of oral hedgehog inhibitors, potentially improving treatment options for patients with basal cell carcinoma.
How similar studies have performed: While this approach is novel in directly comparing vismodegib and sonidegib, previous studies have shown the effectiveness of oral hedgehog inhibitors in treating basal cell carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women * All ages * Diagnosed with locally advanced basal cell carcinoma (laBCC), metastatic basal cell carcinoma (mBCC), multiple basal cell carcinomas or Gorlin syndrome * Use of oral hedgehog inhibitor vismodegib or sonidegib Exclusion Criteria: * None
Where this trial is running
Nijmegen, Gelderland and 7 other locations
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastricht University Medical Center + — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
- Netherlands Cancer Institute - AVL — Amsterdam, North Holland, Netherlands (Recruiting)
- Umcg — Groningen, Provincie Groningen, Netherlands (Not_yet_recruiting)
- Lumc — Leiden, South Holland, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: K Mosterd, MD, PhD — Maastricht University Medical Center
- Study coordinator: Emmy Cruts, MD
- Email: e.cruts@mumc.nl
- Phone: +31(0)43 3877295
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.