Clinical trials: sponsored by Radboud University Medical Center
Metastatic Prostate Cancer
imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS
The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or platinum-therapy).
- Trial name
- PROMPT (NCT04746300)
- Testing
- Biopsy, Blood sample
- Where
- Netherlands
- Volunteers
- 400 people
- Sponsor
- Radboud University Medical Center
Diabetes Mellitus, Diabetes Mellitus, Type 2
Glucagon Like Peptide 1 Receptor (GLP1R) Expression and Beta-cell Mass in Patients With Type 2 Diabetes
Validation of the exendin-based beta cell imaging technique in patients with type 2 diabetes
- Trial name
- GLP1R-T2D (NCT04733508)
- Testing
- 111In-DTPA-exendin-4, IRDye800CW-exendin-4
- Where
- Netherlands
- Volunteers
- 28 people
- Sponsor
- Radboud University Medical Center
Vascular Malformations
Treatment of Congenital Vascular Malformations Using Sirolimus: Improving Quality of Life
Congenital vascular anomalies are uncommon and belong to the group of rare diseases.These vascular malformations can cause serious complications including obstruction of vital organs and their function, recurrent infection and…
- Trial name
- Sirolimus (NCT03987152)
- Testing
- Sirolimus
- Where
- Netherlands
- Volunteers
- 75 people
- Sponsor
- Radboud University Medical Center
SARS-CoV-2 Infection
Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients
In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who…
- Trial name
- MuCo (NCT04590352)
- Testing
- nasopharyngeal and throat swab, collection of mucosal lining fluid, blood collection via fingerprick
- Where
- Netherlands
- Volunteers
- 187 people
- Sponsor
- Radboud University Medical Center
Glioblastoma Multiforme
18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme
This is a pilot study to determine uptake of PET tracer 18F-PSMA-1007 in primary glioblastoma.
- Trial name
- PSMA-GBM (NCT04588454)
- Testing
- 18F-PSMA-1007 PET tracer
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Radboud University Medical Center
Breast Cancer, Breast Neoplasms
Adherence Improving Self-Management Strategy (AIMS) in Breast Cancer Patients Using Adjuvant Endocrine Treatment (AET)
Background of the study: Breast cancer is the most prevalent cancer in Dutch women. Adjuvant endocrine therapy (AET) substantially improves chances for survival after primary breast cancer.
- Trial name
- NCT04719455
- Testing
- Adherence Improving self-Management Strategy, Regular care
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- Radboud University Medical Center
Distal Radius Fracture
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
Distal radius fracture (DRF) is a common fracture of which the incidence appears to be increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.
- Trial name
- Cast-OFF (NCT03240471)
- Testing
- One week of plaster cast, Four-Five weeks of plaster cast
- Where
- 3 sites in Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Rare Bleeding Disorders
Rare Bleeding Disorders in the Netherlands
Rationale: Rare bleeding disorders (deficiency of fibrinogen, factor II, V, V\&VIII, VII, X, XI, XIII, α2-antiplasmin or plasminogen activator inhibitor 1) are not well defined with respect to their clinical phenotype, laboratory…
- Trial name
- RBIN (NCT03347591)
- Testing
- WES, Several assays
- Where
- 7 sites in Netherlands
- Volunteers
- 300 people
- Sponsor
- Radboud University Medical Center
Myelodysplastic Syndromes (MDS)
A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
Study Objectives: To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the World Health Organization…
- Trial name
- EUMDS (NCT00600860)
- Testing
- No interventions
- Where
- 18 sites in Austria, Croatia and 16 more
- Volunteers
- 4,000 people
- Sponsor
- Radboud University Medical Center
Leukemia, Myelodysplastic Syndrome
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative…
- Conditions
- Leukemia, Myelodysplastic Syndrome, Leukemia, Myeloid, Acute
- Trial name
- ANIDULAPK (NCT01249820)
- Testing
- anidulafungin 200 mg q48h, anidulafungin 300 mg q72h
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Radboud University Medical Center
Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
The primary objective of this trial is as follows: To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or…
- Conditions
- Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia, Myelo Dysplastic Syndrome
- Trial name
- MATADOR (NCT02172768)
- Testing
- alternate dosing, daily dosing, micafungin
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Gastrointestinal Stromal Tumor, Major Gastrectomy
Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy
The most common sites for GIST to occur are the stomach (60-70%) and proximal small intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor resection or palliative surgery which might affect…
- Trial name
- ABILITY (NCT02185937)
- Testing
- cola
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Radboud University Medical Center
Varicella Zoster Virus Infection, Herpes Simplex Virus Infection
Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir
A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new…
- Trial name
- VALID-I (NCT01689285)
- Testing
- valacyclovir tablet, valacyclovir oral solution
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Hepatitis C Infection, Depression
Interaction Between Paroxetine and Telaprevir
Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV infected patients.Telaprevir has been…
- Trial name
- ROLEX (NCT01841502)
- Testing
- Paroxetine, telaprevir
- Where
- 7 sites in Netherlands
- Volunteers
- 3 people
- Sponsor
- Radboud University Medical Center
HCV Coinfection, Hepatitis C
Evaluation of RIBAvirin Plasma COncentrations in Patients With Chronic Hepatitis C Infection Routinely Treated With Modern DAA Regimens
The aim of this study is to evaluate RBV plasma concentrations when used in combination with newly developed DAA combinations. If possible, its correlations with SVR rates and incidence of anaemia will be assessed in HCV-patients.
- Trial name
- RIBACOP (NCT02505243)
- Where
- Netherlands
- Volunteers
- 252 people
- Sponsor
- Radboud University Medical Center
HCV
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor…
- Trial name
- CRUSADE-1 (NCT03389061)
- Testing
- sofosbuvir/velpatasvir tablet, sofosbuvir/velpatasvir crushed
- Where
- 3 sites in Germany, Netherlands
- Sponsor
- Radboud University Medical Center
HIV-1 Infection
Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen
During the past years the treatment of HIV-1 infection has transformed towards chronic treatment. Patients are being treated with antiretroviral drugs for many years and become older.
- Trial name
- PRADAII (NCT02566707)
- Testing
- Atazanavir, Dolutegravir, Lamivudine
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 9 people
- Sponsor
- Radboud University Medical Center
Hepatitis C, HIV
A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat
This study aims to provide the evidence that 150mg of cobicistat will have the same effect on the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with atazanavir 300mg.
- Trial name
- DATE-4 (NCT02565888)
- Testing
- Daclatasvir, Atazanavir, Ritonavir
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Hepatitis C, Diabetes Mellitus
A Drug-drug Interaction Study Between Daclatasvir and Metformin
This study aims to provide clinical information on a potential drug-drug interaction between daclatasvir and metformin.
- Conditions
- Hepatitis C, Diabetes Mellitus, Insulin Resistance
- Trial name
- DATE-3 (NCT02565862)
- Testing
- Daclatasvir, Metformin
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV
Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet
Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®) and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as TRI).
- Trial name
- SCRUM (NCT02569346)
- Testing
- Triumeq, Triumeq crushed + breakfast, Triumeq crushed + drip feed
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center