About Clinical Research Unit

Facilities and staff - CRU ​

  • 1 professor, 15 study coordinators, 1 lead study coordinator, 4 lab technicians, 2 secretaries, 1 statistician and 1 data manager
    • Certified, trained and working according to GCP. Updated GCP training/ course at least every second year
    • Experienced in web-based electronic data capture and easy access to a computer with high-speed web/internet
    • Resources to complete data entry and resolve queries 
    • Availability of workspace for Monitors to perform regular site visits, including ability to access the electronic data capture website
    • Experienced in using RECIST 1.1 and irRECIST to evaluate tumour response
  • A laboratory which includes a (blood) sample preparation area containing equipment for processing and storage of study samples in compliance with GLP and GCP
    • Staff trained to collect, process and ship samples, completing tracking logs on an ongoing basis
  • -20° C and -80° C freezers available with ample space for storage of study samples
  • Experience in design of protocols (inclusive phase 1; first in human), design and administration of data bases and development of computerized trial management software including eCRFs (OpenClinca) and randomization

Facilities and staff ECTU (Experimental Cancer Therapy Unit)

  • Outpatient clinic
  • 1 professor, 2 senior physicians, 10 nurses, 1 head nurce of unit,​ and 2 secretaries
    • Certified, trained and working according to GCP. Updated GCP training/ course every second year
    • Experienced and trained in emergency situations (physicians and study nurses) and in the
      management of safety events (e.g. immune-related)
  • Facilities for close patient surveillance, including equipment for continuous cardiac monitoring
    • Seven days a week coverage with facilities for overnight stay
      (co-operation with in-patient ward)
  • Close co-operation with Intensive Care Unit and 24-hour access to the hospital Emergency Response Team
  • 24-hour facilities for standard blood sample analysis with expedited processing
  • Fully equipped facilities for first-in-man studies
  • 8 beds, 4 - 6 treatment chairs and 3 outpatient consulting rooms
  • A laboratory which includes a (blood) sample preparation area containing equipment for processing and storage of study samples in compliance with GLP and GCP
    • Staff trained to collect, process and ship samples, completing tracking logs on an ongoing basis

Quality

  • Inspected by Danish Health Authority Inspectors in January 2015 without critical findings
  • Audit by GCP Unit in November 2015 without critical findings
  • Internal quality assurance systems (Site SOPs continuously revised)
  • Complies with all legal requirements and the EU Directive on Clinical Trials (Directive 2005/28/EF & Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal for human use)
Experience in educational activities including training courses and workshops e.g.  GCP and RECIST

 Collaboration

  • Pharmaceutical Industry
    • BMS, Novartis, Bayer, Pfizer, Roche, MSD, Astra Zeneca, Abbot, Glaxo Smith Cline, Abbvie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Merck Serono, Alligator, Sanofi among others
  • EORTC
  • AGO, CLCG, NSGO, DAHANCA, NUCOG, SPCG, IBCSG/DBCG among others
  • Nordic Network for Early Cancer Trials (Nordic-NECT)
  • NEXT – National Experimental Partnership
  • "In house  trials" in collaboration with
    • Centre for Cancer Research
    • Centre for Cancer Immune Therapy (CCIT)
  • "In house" collaborators:
    • Inge Marie Svane, Professor, MD, Director CCIT
    • Julia Sidenius Johansen, Professor, MD
    • Daniel Hargbøl Madsen, senior researcher CCIT

Tumour biopsy collection

  • Ability to collect sequential biopsies at required time-points with an established process for taking tumour biopsies from either deep or superficial lesions
  • Ability to process the samples immediately (formalin, transfer medium, snap frozen, fixation)
  • Biobank for various tumour types

Molecular and biochemical analyses

  • Routine laboratory assessments including biomarkers
  • Immunohistochemistry and immunological assays
  • Receptor expression and functional receptor analyses
  • Protein analyses (ELISA, RIA and immunohistochemistry)
  • MicroRNA gene analyses​
  • Gene profiling with individually designed panels dependent on target and pathway as a standard of care
  • ​Weekly meeting of the  tumour board

​​Genomic profiling

Next Generation Sequencing (NGS) is routinely performed (new biopsy/archived material) using the following assays​

  • Oncoming focus assay (+ BRCA 1/2 for ovarian/breast)
    • DNA and RNA sequencing of 52 genes (209 DNA amplicons and 271 RNA amplicons) relevant for solid tumors - directed against tumor genes targeted by on-marked oncology drugs and published evidence
  • Oncoming comprehensive assay (from December 2015)
    •  Approximately 143 genes (2531 DNA amplicons and 207 RNA amplicons)
  • Amplications (increased gene copy number) are verified by FISH/IHC

​PET and NMR (functional) imaging

  • Senior technicians and radiologist dedicated to the clinical studies
  • Access to 3 PET-CT scanners (2 Siemens and 1 Philips) and one Cyclotrone
  • Access to MRI (1.5 and 3 tesla)
  • Access to CT scanners (slice CT scans, dynamic CT)
  • Access to ultrasound with Doppler and contrast enhancement
  • Access to a variety of other interventional diagnostic radiology and clinical physiological assessments

Point of excellence

  • First-in-man studies
  • Gene profiling
  • Biobank for different types of cancer
  • Clinical studies with translational research as an important part
  • Clinical studies with radiotherapy
  • Intraperitoneal therapy
  • Intratumoral therapy
  • Electroporation therapy
  • TACE – Trans Arterial Chemoembolization
  • GMO studies
  • Immunotherapies
    • GMP-certified laboratory for preparation of therapeutic cellular products and evaluations/monitoring of immune responses
    • Production of both T-cells and DCs (including mRNA transfection) for clinical use
    • TILS
    • Dendritic cell vaccination

​Approval process

  • External review board:
    DMHA 4-6 weeks,  EC  4-6 weeks
  • Internal
    All protocols will be presented at the Department of Oncology Internal Review Board
  • All contracts with industry are handled by VIF (legal review )​

​Patient population; number of new patients:

The Danish population:  5.5 million
Number of new cancer cases (2009-2013):  35,471







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