The Clinical Trial Unit+ is a team of experienced Clinical Trial Managers who coordinate Clinical Trials in which the Precision Medicine Department is involved as Sponsor or partner. The CTU has 4 objectives:
1) Initiation, coordination and management of Interventional and non-WMO clinical trials
2) Creative data management to find, organize and (re)use clinical FAIR data
3) Patient-centered virtual clinical trials by using m-health and e-health applications
4) In silico trials
Current Clinical Trials
IMMUNOSABR (Interventional)
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer
NCT 03705403Tumagnostic (Interventional)
A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of CP-506, a tumor agnostic HAP in patients with HRD/FAD solid tumors or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumor and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial
NCT 04954599iCOVID (non-WMO)
The icovid project is the continuation of the pro bono Belgian icovid initiative, which resulted in the development of icolung, a lung imaging AI solution. Co-funded by the EU Horizon 2020 program, the project has grown into a multicenter European project aiming to further develop and roll out icolung into 800 European centers. icolung, a cloud-based AI software for the analysis of non-contrast chest CT helps detect COVID-19 at an early stage and quantifies the extent of lung lesions
AI models for severity risk assessment and triage for COVID-19 patients at hospital admission
More informationPatient Decision Aid (PDA) in Non-Small Cell Lung Cancer (non-WMO)
Quantitative and qualitative study for validation of a newly developed PDA to improve shared decision making between Patient and Healthcare providers
mtDNA-COVID (non-WMO)
mtDNA and SNPs to predict severity of COVID-19 infection
NCT 04750330DRAGON (Consortium)
Dragon (The RapiD and SecuRe AI enhAnced DiaGnosis, Precision Medicine and Patient EmpOwerment Centered Decision Support System for Coronavirus PaNdemics) is a Innovative Medicines Initiative (IMI) project. It started on 1 October 2020 and will run for three years, will help to identify patients who have got COVID-19 or novel coronaviruses that may arise in the future. DRAGON uses artificial intelligence (AI) and machine learning to deliver a decision support system for precise coronavirus diagnosis using CT scanning. It also aims to be able to better predict the outcomes of patients. The DRAGON project is coordinated by the University of Maastricht with Radiomics as the Project Lead, and partners which are comprised of high-tech small and medium sized enterprises (SMEs), academic research institutes, biotechnology and pharmacological partners, and ELF and ERS. At the end of the DRAGON project, patients will be more aware of what to do and clinicians will have a better understanding of the perspectives of patients.
DRAGON websiteWhat do we do?
Clinical Trials
Stage 1 - Submission clinical trials
Protocol development
Ethical approval (both WMO and non-WMO)
Logistical implementation
Development of Data Management Plan
Stage 2 - Coordination of clinical trials
Data collection and data ‘monitoring’
Transfer agreements
Pharmacovigilance
Stage 3 - Closure of clinical trials
Storage of data (digital and materials)
FAIR use of data
Support
PhDs/Researchers with their trials
Supervision of BSc or MSc interns
Tutoring/mentoring students
Grant management
Requesting new grants
Submission of deliverables for European Projects
ClincalTrials.gov
Management of users and Protocol Registration and Results System (PRS) for Maastricht University
Team
Anshu Ankolekar
Lindsay Hewitt
Lisanne Eppings
Jorge Almeida
Philippe Lambin
