CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice

Completed

• Conditions: Metastatic Medullary Thyroid Cancer
• Interventions: Drug: Caprelsa

• Registration Number: NCT02109250
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

In this registry it is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).

The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore real life data regarding demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be included.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all Belgian patients treated with Caprelsa® (vandetanib)	Caprelsa	It is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).

Primary Outcome Measures

Name	Time	Method
The primary objective of this registry is to describe the characteristics of patients who receive Caprelsa® and who are fulfilling the reimbursement criteria.	Up to 16 months	In this registry the following real life data will be collected: demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with vandetanib and time of progression or death (if applicable).

Trial Locations

Locations (8)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

UZ Brussel; 🇧🇪 Brussels, Belgium

UCL St-Luc; 🇧🇪 Brussels, Belgium

CH de Wallonie; 🇧🇪 Tournai, Belgium

Clinique du Sud Luxembourg; 🇧🇪 Arlon, Belgium

AZ Klina; 🇧🇪 Brasschaat, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium