Clinical trials: sponsored by UMC Utrecht
Cancer
The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life
A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life.
- Trial name
- GLINK (NCT07110753)
- Testing
- combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse, short online lifestyle intervention by lifestyle coach and educational materials after 6 months
- Where
- Netherlands
- Volunteers
- 221 people
- Sponsor
- UMC Utrecht
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Hypoxic-ischemic brain injury (HIBI) is a leading cause of death and lifelong disability in near-term and term infants, most often caused by perinatal arterial ischemic stroke (PAIS, incidence approximately 1:5000 live births) or…
- Conditions
- Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia, Hypoxic-Ischemic Brain Injury, PAIS
- Trial name
- iSTOP-CP (NCT07831746)
- Testing
- MSC, marrow
- Volunteers
- 162 people
- Sponsor
- UMC Utrecht
Acute Otitis Media, Pain
Analgesic Ear Drops for Children With Acute Otitis Media
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM.
- Trial name
- OPTIMA (NCT05651633)
- Testing
- lidocaine hydrochloride 5mg/g
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- UMC Utrecht
Breast Cancer, Cardiovascular (CV) Risk
Multicenter Cardiac Decision Impact Study in People With Breast Cancer
Background: Breast cancer is the most common cancer in women, and advances in early detection and treatment have led to steadily improved survival rates. Today, nearly 80% of breast cancer survivors are over 50 years of age.
- Conditions
- Breast Cancer, Cardiovascular (CV) Risk, Coronary Artery Calcifications
- Trial name
- CarDI (NCT07703033)
- Testing
- Measuring coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans and communicating the associated risk of cardiovascular disease to the patient.
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- UMC Utrecht
Refractory Epilepsy in Children, Refractory Epilepsy
Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials
The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol.
- Conditions
- Refractory Epilepsy in Children, Refractory Epilepsy, Epilepsy
- Trial name
- CBD-uN1que (NCT07668856)
- Testing
- Cannabidiol (CBD) oral solution
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- UMC Utrecht
Spinal Cord Injury, Tetraplegia C1-C4
Innovative Brain-Computer Interface for People With Spinal Cord Injury
The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury.
- Conditions
- Spinal Cord Injury, Tetraplegia C1-C4, Quadriplegia
- Trial name
- INTENSE-BCI (NCT07640711)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- UMC Utrecht
Colorectal Neoplasms, Esophageal Neoplasms
Phase I Platinum Based Chemotherapy Plus Indomethacin
Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are recruited to the stroma of both the primary tumor and metastasis.
- Conditions
- Colorectal Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms
- Trial name
- PIFA (NCT01719926)
- Testing
- Indomethacin
- Where
- 4 sites in Netherlands, Switzerland
- Volunteers
- 13 people
- Sponsor
- UMC Utrecht
Glioblastoma
Glioblastoma Targeted Treatment Option Maximization by WGS
In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates.
- Trial name
- GLOW (NCT05186064)
- Testing
- whole genome sequencing
- Where
- Netherlands
- Volunteers
- 164 people
- Sponsor
- UMC Utrecht
Colorectal Cancer Metastatic
Radioembolization in Elderly/ Fragile Patients With mCRC
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter.
- Trial name
- CAIRO7 (NCT05092880)
- Testing
- radioembolization, Standard of care first-line systemic therapy
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- UMC Utrecht
Metastatic Colorectal Cancer, Metastatic Cancer to Liver
FAPI Molecular Imaging for Diagnosis of the CMS4 Unfavorable Colorectal Cancer Subtype
Colorectal cancer (CRC) is the 3rd most common cancer worldwide and accounts for ~14,000 new diagnoses and ~5,000 deaths in the Netherlands yearly (1.9 million and 935 thousand on a global level).
- Trial name
- FoCus (NCT06191120)
- Testing
- [18F]-ALF-FAPI-74 PET/CT scan
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- UMC Utrecht
Behcet's Disease, Idiopathic Inflammatory Myopathies
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations.
- Conditions
- Behcet's Disease, Idiopathic Inflammatory Myopathies, IgG4-related Disease
- Trial name
- DRIMID (NCT06285539)
- Testing
- Filgotinib
- Where
- 6 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
Circulating Tumor DNA, Recurrence
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy.
- Conditions
- Circulating Tumor DNA, Recurrence, Colon Cancer Stage II
- Trial name
- CrEATE (NCT06434896)
- Testing
- ctDNA analysis after surgery
- Where
- 29 sites in Netherlands
- Volunteers
- 1,320 people
- Sponsor
- UMC Utrecht
Metastatic Breast Cancer
Effects of Exercise in Patients With Metastatic Breast Cancer
Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting.
- Trial name
- EFFECT (NCT04120298)
- Testing
- Supervised exercise
- Where
- Netherlands
- Volunteers
- 357 people
- Sponsor
- UMC Utrecht
Doxorubicin Induced Cardiomyopathy, Chemotherapeutic Toxicity
Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage
The goal of this observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and…
- Conditions
- Doxorubicin Induced Cardiomyopathy, Chemotherapeutic Toxicity, Anthracyclines
- Trial name
- MUSCLE (NCT05731375)
- Testing
- 31-MRS at 7 Tesla (T)
- Where
- 4 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- UMC Utrecht
Neoplasms
Personalized Live-remote Exercise Training for Cancer Survivors
Background Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy.
- Trial name
- LION (NCT06270628)
- Testing
- Exercise group
- Where
- Netherlands
- Volunteers
- 350 people
- Sponsor
- UMC Utrecht
Cleft Palate Children, Cleft Alveolar Ridge
Alveolar Cleft Repair Using Osteoinductive Ceramics
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an…
- Conditions
- Cleft Palate Children, Cleft Alveolar Ridge, Cleft Lip and Palate
- Trial name
- ACROSTIC (NCT05331456)
- Testing
- Unilateral alveolar cleft repair
- Where
- 4 sites in Netherlands
- Volunteers
- 84 people
- Sponsor
- UMC Utrecht
Spinal Metastases
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks…
- Trial name
- BLEND (NCT05575323)
- Testing
- Same-day SBRT and spinal surgery, Standard of care
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- UMC Utrecht
Monoclonal Gammopathy of Uncertain Significance
Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy
The objective of this investigator-initiated phase II single-arm open-label clinical trial is to investigate neurological response rate, safety and tolerability of Zanubrutinib 320 mg daily in combination with Rituximab 375 mg/m2…
- Trial name
- MAGNAZ (NCT05939037)
- Testing
- Zanubrutinib Oral Product
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- UMC Utrecht
Breast Cancer
Cancer Of the BReast Asanas Study (COBRA)
Rationale: Women with hormone-receptor positive breast cancer are usually prescribed endocrine therapy for a period of 5-10 years. This treatment reduces the risk of recurrence and improves overall survival in these women.
- Trial name
- COBRA (NCT06480513)
- Testing
- live yoga, live remote yoga
- Where
- Netherlands
- Volunteers
- 140 people
- Sponsor
- UMC Utrecht
Recurrent Pancreatic Ductal Adenocarcinoma
Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy…
- Trial name
- ARCADE (NCT04881487)
- Testing
- Additional stereotactic body radiation therapy
- Where
- 3 sites in Netherlands
- Volunteers
- 174 people
- Sponsor
- UMC Utrecht