Evaluating oral hedgehog inhibitors for treating basal cell carcinoma in the Netherlands
Official title: 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.
Run by Maastricht University Medical Center · NCT05463757 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 8 sites (Nijmegen, Gelderland and 7 other locations) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT05463757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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 -
Lumc
Leiden, South Holland, Netherlands Recruiting -
Erasmus MC
Rotterdam, South Holland, Netherlands Recruiting
Show 2 more locations
-
UMC Utrecht
Utrecht, Utrecht, Netherlands Recruiting -
Umcg
Groningen, Provincie Groningen, Netherlands Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Raman Spectroscopy to assess skin cancer tumors
This study is testing a new imaging technique to see if it can help doctors better understand the size and spread of skin cancer tumors in patients with basal cell and squamous cell carcinoma.
-
Mobile sun protection support to help young adults stay safe in the sun
This project tests a mobile health program to see if reminders, education, planning tools, and real-time sun exposure information can help young adults protect their skin from excessive sun exposure.
-
AI-based risk and subtype prediction for basal cell carcinoma using dermoscopic images
A retrospective study tests an artificial intelligence model to classify basal cell carcinoma as low- or high-risk and to predict histopathological subtypes from archived dermoscopic images.
-
Methionine-Reduced Diet in Solid Tumors (early-phase)
A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.
-
TriAdeno and N-803 vaccine in early prostate cancer on active surveillance
A vaccine combo called TriAdeno plus the N-803 drug is being tested to see if it can help slow or stop growth in men with early-stage, low- to intermediate-risk prostate cancer who are being watched rather than treated right away.
-
Psycho-physiological profiling of people with low versus high heat resilience
This project will test whether controlled heat and UV exposures plus physiological and psychological measurements can identify healthy adults who are more or less resilient to heat.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.