Phase I and early phase II clinical trials

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Phase I and early phase II clinical trials
The Experimental Cancer Therapy Unit combine an outpatient clinic with a care unit with facilities for close patient surveillance, including equipment for continuous cardiac monitoring. The Unit has 8 beds, 4-6 treatment chairs and three outpatient consulting rooms. In cooperation with our inpatient ward we cover seven days a week.

Professor, DMSc Dorte Nielsen and Peter Grundtvig Sørensen, consultants, are heading the unit and are responsible for most phase I-II early clinical trials.

The dedicated team includes 10 nurses and 2 secretaries.

All staff members are experienced, GCP trained and trained in emergency situations. The Unit has close co-operation with the critical care unit and have 24-hour access to the hospital emergency response team.

The Clinical Research Unit has 14 research nurses, 3 technicians, 2 secretaries and one statistician. The staff has comprehensive experience in developing, planning, implementing and running clinical trials, as well as data management and statistical analysis. The Unit maintains a laboratory which includes (blood) sample preparation area containing equipment for processing and storage of study samples in compliance with GLP and GCP. The Clinical Research Unit technicians are trained in handling blood samples for pharmacokinetics, pharmacodynamics, and translational research. Additionally, tissue sampling and processing for further analysis including snap-freeze technique can be undertaken through our collaboration with the Department of Diagnostic Radiology and the various surgical departments.


PET and NMR functional imaging
There is a close cooperation with the PET and Cyclotrone Unit at the hospital. This unit is equipped with 3 PET-CT scanners (2 Siemens and 1 Philips) and a Cyclotrone. By the end of this year 1-2 more scanners will be available. In addition, we have access to MRI (1.5 and 3 tesla), 64 (Philips Brilliance) and 128 (Siemens Somatom Definition Flash) slice CT scans, dynamic CT, ultrasound Doppler with colour contrast enhancement and a variety of other interventional diagnostic radiology and clinical physiological assessments. A group of senior technicians and radiologist are dedicated to the clinical studies, and the quality is ensured by a close cooperation and coordination. 

Molecular and biochemical analyses
The following analyses can be performed at Department of Pathology and Department of Clinical Chemistry:

  • Immunohistochemistry and immunological assays
  • Receptor expression and functional receptor analyses
  • Protein analyses (ELISA, RIA and immunohistochemical investigations)
  • MicroRNA gene analyses
  • Gene profiling with individually designed panels dependent of target and pathway.


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