Symposium REPORT august Blood- based biomarkers for optimal screening of colorectal neoplasia LÆGERNES FORSIKRINGSFORENING AF 1891

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1 REPORT Symposium august 2014 Blood- based biomarkers for optimal screening of colorectal neoplasia With thanks to: LÆGERNES FORSIKRINGSFORENING AF 1891

2 2-DAY INTERNATIONAL SYMPOSIUM in COPENHAGEN Plus one day of meetings coordinating strategies and possible collaborations focusing on The ideal cancer-associated blood-base biomarker for the purpose of population screening for colorectal cancer (CRC). Monday, August 25 th, : Welcome, aim of the symposium, program Professor Hans Jørgen Nielsen, MD, DMSc, Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark Organizer and project PI : Present FIT screening in Denmark Consultant Berit S. Andersen, MD, Ph.D., Department of Public Health, Randers Hospital, Randers, Denmark : Present guidelines for adenoma classification in Denmark Consultant Morten Rasmussen, MD, Ph.D., Department of Surgical Gastroenterology, Bispebjerg Hospital, Copenhagen, Denmark : The optimal blood-based screening study for CRC Professor David F. Ransohoff, MD, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC, USA and FDA - consultant to Immunology Devices Panel, Center for Devices and Radiological Health : The EDRN/NCI study on blood-based biomarkers in CRC Professor Dean E. Brenner, MD, University of Michigan Internal Medicine Oncology, Ann Arbor, MI, USA PI of the EDRN study on blood-based biomarkers in early detection of CRC : Lunch at the castle, ground level : The Northern Germany study on blood-based biomarkers Professor Jens Habermann, MD, Ph.D., Department of Surgery, Section for Translational Surgical Oncology, University Clinic Schleswig-Holstein, Campus Lübeck, Germany : The German BLITZ study Professor Hermann Brenner, MD, DMSc, Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany : The Danish Endoscopy II study on blood-based biomarkers Professor Hans Jørgen Nielsen, MD, DMSc, Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark Organizer and project PI : Statistics/Bioinformatics on protein profiles in Endoscopy II Susan Gawel, MS, Ph.D., Statistical Project Manager and Quinnie Yang, MS, MD, Senior Statistician, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL, USA : The Architect TM protein biomarker profile in Endoscopy II Gerard Davis, Ph.D., Companion Diagnostics Lead, Abbott Diagnostics Division, R&D, Abbott Laboratories, Abbott Park, IL, USA : Break refreshments 2

3 Monday (continued) : Nucleosome biology, analysis and value in screening for CRC Privat Dozent Stefan Holdenrieder, MD, DMSc, Institute of Biochemistry and Clinical Pharmacology, Rheinische Friedrich-Wilhelms University, Bonn, Germany : Results of nucleosome analyses of the Danish Endoscopy II study CSO Jake Micallef, MD, Belgian Volition SA, Namur, Belgium : Adenomas needed to be detected by blood-based screening of CRC Professor Robert (Rocky) E. Schoen, MD, MPH, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, PA, USA ??.??: Dinner at the castle, ground level all participants and speakers Hotel for Danish non-speakers: SCANDIC, Vester Søgade 6, phone: Tuesday, August 26 th, : The Danish Endoscopy III study ( ) Professor Hans Jørgen Nielsen, MD, DMSc, Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark Organizer and project PI : Circulating tumor-derived DNA in screening for CRC Professor Claus L. Andersen, Group Leader of Colorectal Cancer Research, Department of Molecular Medicine, Institute of Clinical Medicine, University of Aarhus, Skejby, Denmark : Cell free DNA in screening for CRC Molecular Biologist Niels Pallisgaard, MSc, Department of Clinical Biochemistry, Vejle Hospital, Vejle, Denmark : Break refreshments : Metabolomics in screening for CRC Professor Rasmus Bro, VMD, Ph.D., Institute of Food Science, University of Copenhagen, Frederiksberg, Denmark : Cathepsins in screening for CRC Professor Janko Kos, MSc, Ph.D., Institute of Pharmacology, University of Ljubljana, Slovenia : mirna profiles in screening for CRC Scientific Manager Anni Thomsen, MSc, Ph.D., Exiqon A/S, Vedbaek, Denmark : Plasma galectin analytes in screening for CRC Professor Robert Bresalier, MD, Gastroenterology, Hepatology & Nutrition, Division of Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA : Lunch at the castle, ground level 3

4 Tuesday (continued) : supar(i), (II+III) and (I-III) in screening for CRC Group Leader Gunilla Høyer-Hansen, MSc, Ph.D., The Finsen Laboratory and BRIC, National Hospital (Rigshospitalet), Copenhagen, Denmark : Proteomics in early detection of CRC CSO John Blume, MSc, Ph.D., Applied Proteomics Inc., San Diego, CA, USA : YKL-40 in screening for CRC Biostatistician Ib Jarle Christensen, MSc, The Finsen Laboratory and BRIC, National Hospital (Rigshospitalet), Copenhagen, Denmark : Clean colorectum and subsequent risk of malignancy? Professor Hans Jørgen Nielsen, MD, DMSc, Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark Organizer and project PI : Break refreshments : What does it take to implement blood-based screening for CRC? panel discussion Panelists: Professor David F. Ransohoff, Chapel Hill, NC, USA Chief Physician Iben Holten, MD, DMSc, Danish Cancer Society, Copenhagen, Denmark Professor Rocky Schoen, Pittsburgh, PA, USA Professor Bob Bresalier, Houston, TX, USA Consultant Surgeon Morten Rasmussen, BBH, Copenhagen, Denmark Chairs: Professor Nils Brünner, MD, DMSc, Head of Laboratory, Department of Veterinary Disease Biology, Section for Molecular Biology, University of Copenhagen, Frederiksberg, Denmark Professor Hans Jørgen Nielsen, Hvidovre, Denmark Guided tour on the history of the palace ??.??: Speakers Dinner at the castle, lower level. Bernstorff Slot / Bernstorff Palace Jaegersborg Allé Gentofte Denmark Phone: info@bernstorffslot.dk 4

5 Attendees: Attendees speakers included: EUROPE: Belgium Thomas Bygott, BSc, Marketing Director, Belgian Volition SA, Namur Mark Eccleston, CSO, MSc, Ph.D., Belgian Volition SA, Namur Marielle Herzog, MSc, Ph.D., Lead Scientist, Belgian Volition SA, Namur Jake Micallef, CSO, Ph.D., MBA, Belgian Volition SA, Namur Cameron Reynolds, CEO, MBA, Belgian Volition SA, Namur Germany Hermann Brenner, MD, DMSc, Professor of Epidemiology, DKFZ, Heidelberg Jens Habermann, MD, Ph.D., Professor of Surgery, University of Schleswig-Holstein, Lübeck Stefan Holdenrieder, MD, DMSc, Privat dozent, University of Bonn, Bonn Italy: Marta Bevilacqua, MSc, Research Assistant, University of Roma Slovenia Janko Kos, MSc, Ph.D., Professor of Pharmacology, University of Ljubljana, Ljubljana USA: California John Blume, CSO, MSc, Ph.D., Applied Proteomics, San Diego Illinois Susan Brophy, Ph.D., Principal Research Scientist, Abbott Diagnostic Division, Abbott Park Gerard Davis, Ph.D., Companion Diagnostic Lead, Abbott Diagnostic Division, Abbott Park Yiu-Lian Fong, Ph.D., Divisional Vice President, R&D, Abbott Molecular Division, Des Plaines Susan Gawel, Ph.D., Statistical Project Manager, Abbott Diagnostic Division, Abbott Park Esther Yang, Ph.D., Sr. Director, Assay Development, Abbott Diagnostic Division, Abbott Park Quinnie Yang, MD, Senior Statistician, Abbott Diagnostic Division, Abbott Park Michigan Dean Brenner, MD, Professor of Medical Oncology, University of Michigan, Ann Arbor North Carolina David Ransohoff, MD, Professor of Medicine, University of N. Carolina at Chapel Hill Pennsylvania Robert Schoen, MD, Professor of Gastroenterology, University of Pittsburgh, Pittsburgh Texas Robert Bresalier, MD, Professor of Gastroenterology, MD Anderson Cancer Center, Houston 5

6 Attendees: DENMARK: Bispebjerg Hospital, Copenhagen Tina Brønnum, Research Nurse Stine Gerhardt, Research Nurse Janne H. Hammer, MD, Consultant Surgeon Lars N. Jørgensen, MD, DMSc, Professor of Surgery Morten Rasmussen, MD, Ph.D., Consultant Surgeon Dako A/S, Glostrup Sven Müller, MSc, Ph.D., Sr. Research Manager David Hersi Smidt, Ph.D., Research Scientist Danish Cancer Society, Copenhagen Nils Brünner, MD, DMSc, Professor of Oncology Iben Holten, MD, DMSc, Chief Physician José Moreira, MSc, Ph.D. Jørgen H. Olsen, MD, DMSc, Head of Research Jan Stenvang, MSc, Ph.D., Lecturer Anne Tjønneland, MD, Ph.D., Head of Division Exiqon A/S, Vedbæk Anni Thomsen, MSc, Ph.D., Scientific Manager Peter Mouritzen, MSc, Ph.D., Vice President R&D Finsen Laboratory and Biotech Research and Innovation Center, Copenhagen Ib Jarle Christensen, MSc, Lead Biostatistician Gunilla Høyer-Hansen, MSc, Ph.D., Group Leader, Ruth Petterson, Research Biotechnician Tine Thurison, Ph.D., Post Doc Gentofte Hospital, Gentofte Morten A. Rasmussen, MSc, Ph.D., Post Doc Herlev Hospital, Herlev Anders Fischer, MD, DMSc, Consultant Surgeon Jakob W. Hendel, MD, Ph.D., Consultant Gastroenterologist Charlotte Vauvert, Assistant matron, Endoscopy Unit Herning Hospital, Herning Mogens R. Madsen, MD, Consultant Surgeon Annette H. Larsen, Research Nurse Susie L. Larsen, Research Nurse 6

7 Attendees: Hillerød Hospital, Hillerød Tine Vester Christensen, Research Nurse Thore Hillig, Ph.D., Molecular Biologist Søren Kristiansen, MSc, Biochemist Georg Söletormos, MD, DMSc, Head of Laboratory Jesper Vilandt, MD, Consultant Surgeon Horsens Hospital, Horsens Kirsten Kallestrup, Research Nurse Michael Klærke, MD, Consultant Surgeon Hvidovre Hospital, Hvidovre Jens Andersen, MD, Consultant Surgeon Ove Andersen, MD, Ph.D., Head of Clinical Research Thue Bisgaard, MD, DMSc, Professor of Surgery Maria Boldreel, Assistant matron, Endoscopy Unit Amager Jacob Bunkenborg, MSc, Ph.D., Chemist Rajenda S. Garbyal, MD, Consultant Pathologist Emilie Hammer, Research Assistent Martin H. Hansen, MD, Resident Gastroenterologist Tine Plato Hansen, MD, DMSc, Consultant Pathologist Stefan Haraldson, MD, Ph.D., Resident Gastroenterologist Peter Hesselfeldt, MD, Consultant Surgeon Karen Vibeke Jakobsen, MSc, Project Manager Tine Karbo, Assistant matron, Endoscopy Unit Thomas Kring, MS, Research Assistant Torben Mogensen, MD, DMSc, Medical Director Hans Jørgen Nielsen, MD, DMSc, Professor of Surgical Oncology Tina Serup Olsen, Research Secretary Niels Pedersen, MS, Research Assistant Thomas Piper, MS, Research Assistant Jørgen H. Poulsen, MD, DMSc, Consultant Biochemist, Head of Laboratory Louise Rasmussen, MD, Ph.D. Student Eva Rømer, Research Nurse, Hvidovre Hospital, Hvidovre Svend Schulze, MD, DMSc, Consultant Surgeon, Head of Department Bo Søndergaard, MD, Ph.D., Consultant Gastroenterologist Steen Sørensen, MD, DMSc, Consultant Biochemist Line Toft Tengberg, MD, Ph.D. Student Christina Therkildsen, Ph.D., Post Doc Sarah Vendrup, Screen Team Nurse, Endoscopy Unit Amager Michael Wilhelmsen, MD, DMSc Student 7

8 Attendees: Innovation Foundation, Copenhagen Lotte Jansen, Ph.D., Project Manager National Hospital (Rigshospitalet), Copenhagen Bodil Engelmann, MD, DMSc, Resident Oncologist Odense Hospital, Odense Henrik Ditzel, MD, DMSc, Professor of Molecular Biology, Head of Laboratory Randers Hospital, Randers Lars M. Andersen, MD, Consultant Surgeon, Head of Department Berit S. Andersen, MD, Ph.D., Consultant of Health Science Rikke Demming, Research Nurse Mette Giørtz, Research Nurse Skejby Hospital, Skejby Claus L. Andersen, MSc, Ph.D., Professor, Leader of CRC Research Jesper Bramsen, MSc, Ph.D., Associate Professor Torben Ørntoft, MD, DMSc, Professor of Biochemistry, Chief of Laboratory University of Copenhagen, Campus Frederiksberg Rasmus Bro, VMD, Ph.D., Professor, Institute of Food Science Vejle Hospital, Vejle Rikke Fredslund, MSc, Ph.D., Molecular Biologist Anders Jakobsen, MD, DMSc, Professor of Oncology Niels Pallisgaard, MSc, Lead Molecular Biologist Viborg Hospital, Viborg Bibi Damsgaard, Research Nurse Ali Kahlid, MD, Consultant Surgeon Aarhus Hospital THG, Aarhus Søren Laurberg, MD, DMSc, Professor of Surgery Knud T. Nielsen, MD, Consultant Surgeon, Head of Department 8