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The KKS Marburg

The Coordinating Centre for Clinical Trials Marburg founded in April 2000 is specialized in subject-specific modules in different areas of clinical research.

The Coordinating Centre for Clinical Trials Marburg (KKS Marburg)

The KKS Marburg is an independent facility of the Medical Faculty of the Philipps University of Marburg, which supports clinical trials on oncology, internal medicine, cardiology, surgery, neurology and orthopedics.

In recent years, the KKS Marburg has established several subject-specific modules in cooperation with other institutes of the University of Marburg. The KKS Marburg also cooperates with well-known study groups, such as the study group on gynecological oncology (German abb.: AGO), German Parkinson Study group (GPS), the Eating disorder network (EDNET), the Lungcancer study group (AktionBronchialkarzinom) or the European Network for the Study of Adrenal Tumours (ENSAT). At present, the following modules are available at the KKS Marburg:

Module HEALTH ECONOMICS

Within the context of the module ‘Health Economics’, the KKS Marburg supports several clinical trials in cooperation with Professor Richard Dodel, MD, from the Centre for Mental Disorders in Marburg.

The profitability of medical interventions is assessed by means of instruments of economic evaluation research. The results of these investigations assist decision-makers, such as health insurance companies and physicians, in the efficient application of alternative treatment methods.

The module ‘Lung‘ founded by the LOEWE program

(Program of the German Federal State of Hessen for the development of scientific and economic excellence ─ German Abb.: LOEWE)

Within the context of the second excellence initiative funding series tendered by the State of Hessen, the project ‘UGMLC – Universities of Giessen and Marburg Lung Centre: Inflammatory and Hyperproliferative Diseases of the Lung and Respiratory Tract’ was awarded an overall amount of € 15.1 million from 1 January 2010 onwards. This project is one of the LOEWE research projects, and the KKS Marburg is responsible for the pooling of clinical study activities across the different study sites.

Overall aim of the translational-oriented research centre UGMLC is to connect basic research with patient-oriented research in order to improve diagnostic and therapeutic concepts for patients with lung diseases. Thus, the module ‘Lung’ has been established providing the UGMLC with professional expertise on biometrics and the implementation of clinical trials.

Module ‘Genomics‘

The module ’Genomics’ is the response of the KKS Marburg to the increasing importance of genetic analyses with regard to the genetic predisposition of diseases, diseases due to previous treatments as well as genetic modifications of tissue. In cooperation with the Centre for Genetic Epidemiological Methods of the Institute of medical biometry and epidemiology Marburg, the KKS Marburg provides the necessary structures for the implementation of clinical trials according to GCP requirements and offers profound experience in genetic biostatistics. The clinical trials involved in the KKS module ’Genomics’ range from research into the genetic causes and mechanisms of complex diseases in large clinical trials on population genetics (HapMap projects) to the clinical application of molecular genetic markers for optimising diagnostics, therapies and prevention.

The study program ‘Clinical evaluation‘: Qualification of clinical research staff

The study program ‘Clinical Evaluation‘ ─ conducted by the KKS Marburg in cooperation with the Medical Faculty ─ has gained nationwide attention. The program is headed by Professor Norbert Donner-Banzhoff, MD, and directed at physicians of the University of Marburg and the other two University Hospitals in the State of Hessen. The program consists of 17 classroom instruction blocks of 4 hours each and is available to 12 participants once a year. The various instruction blocks are taught in weekly turns by 19 lecturers from different clinics and institutes, who are experienced in clinical research.

Publications 2014

  • Du Bois, A., Floquet, A., Kim, J. W., Rau, J., Del Campo, J. M., Friedlander, M., Pignata, S., Fujiwara, K., Vergote, I., Colombo, N., Mirza, M. R., Monk, B. J., Kimmig, R., Ray-Coquard, I., Zang, R., Diaz-Padilla, I., Baumann, K. H., Mouret-Reynier, M. A., Kim, J. H., Kurzeder, C., Lesoin, A., Vasey, P., Marth, C., Canzler, U., Scambia, G., Shimada, M., Calvert, P., Pujade-Lauraine, E., Kim, B. G., Herzog, T. J., Mitrica, I., Schade-Brittinger, C., Wang, Q., Crescenzo, R. & Harter, P. 2014. Incorporation of Pazopanib in Maintenance Therapy of Ovarian Cancer. J Clin Oncol.
  • Funck, R. C., Mueller, H. H., Lunati, M., Piorkowski, C., De Roy, L., Paul, V., Wittenberg, M., Wuensch, D. & Blanc, J. J. 2014. Characteristics of a large sample of candidates for permanent ventricular pacing included in the Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization Study (BioPace). Europace, 16(3), 354-62.
  • Herpertz-Dahlmann, B., Schwarte, R., Krei, M., Egberts, K., Warnke, A., Wewetzer, C., Pfeiffer, E., Fleischhaker, C., Scherag, A., Holtkamp, K., Hagenah, U., Buhren, K., Konrad, K., Schmidt, U., Schade-Brittinger, C., Timmesfeld, N. & Dempfle, A. 2014. Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial. Lancet, 383(9924), 1222-9.
  • Maschuw, K., Heinz, C., Maurer, E., Reuss, A., Schade-Brittinger, C. & Bartsch, D. K. 2014. Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections--INTRANS: study protocol for a randomized controlled trial. Trials, 1525.
  • Schüpbach, W. M. M., Rau, J., Houeto, J.-L., Krack, P., Schnitzler, A., Schade-Brittinger, C., Timmermann, L. & Deuschl, G. 2014. Myths and Facts About the EARLYSTIMStudy. Movement Disorders, n/a-n/a.

Publications 2013

  • Arnold, R., Wittenberg, M., Rinke, A., Schade-Brittinger, C., Aminossadati, B., Ronicke, E., Gress, T. M., Mueller, H. H. & Promid Study Group 2013. Placebo controlled, double blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors (PROMID): Results on long-term survival. ASCO Meeting Abstracts, 31(15_suppl), 4030.
  • Bauerschlag, D. O., Hilpert, F., Meier, W., Rau, J., Meinhold-Heerlein, I., Maass, N., Dubois, A., Sehouli, J., Arnold, N., Schem, C., Oberg, H. H. & Baumann, K. 2013. Evaluation of potentially predictive markers for anti-angiogenic therapy with sunitinib in recurrent ovarian cancer patients. Transl Oncol, 6(3), 305-10.
  • Deuschl, G., Schade-Brittinger, C. & Agid, Y. 2013. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med, 368(21), 2038.
  • Deuschl, G., Schupbach, M., Knudsen, K., Pinsker, M. O., Cornu, P., Rau, J., Agid, Y. & Schade-Brittinger, C. 2013. Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study. Parkinsonism Relat Disord, 19(1), 56-61.
  • Dodel, R., Schade-Brittinger, C. & Diener, H. C. 2013. Worauf kommt es beim Lesen von Therapiestudien an? Akt Neurol, 36(01), 22-28.
  • Du Bois, A., Ewald-Riegler, N., De Gregorio, N., Reuss, A., Mahner, S., Fotopoulou, C., Kommoss, F., Schmalfeldt, B., Hilpert, F., Fehm, T., Burges, A., Meier, W., Hillemanns, P., Hanker, L., Hasenburg, A., Strauss, H. G., Hellriegel, M., Wimberger, P., Keyver-Paik, M. D., Baumann, K., Canzler, U., Wollschlaeger, K., Forner, D., Pfisterer, J., Schroder, W., Munstedt, K., Richter, B., Kommoss, S. & Hauptmann, S. 2013. Borderline tumours of the ovary: A cohort study of the Arbeitsgmeinschaft Gynakologische Onkologie (AGO) Study Group. Eur J Cancer.
  • Fensterer, H., Schade-Brittinger, C., Muller, H. H., Tebbe, S., Fass, J., Lindig, U., Settmacher, U., Schmidt, W. E., Marten, A., Ebert, M. P., Kornmann, M., Hofheinz, R., Endlicher, E., Brendel, C., Barth, P. J., Bartsch, D. K., Michl, P. & Gress, T. M. 2013. Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol.
  • Funck, R. C., Mueller, H. H., Lunati, M., Piorkowski, C., De Roy, L., Paul, V., Wittenberg, M., Wuensch, D. & Blanc, J. J. 2013. Characteristics of a large sample of candidates for permanent ventricular pacing included in the Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization Study (BioPace). Europace.
  • Harter, P., Sehouli, J., Kimmig, R., Rau, J., Hilpert, F., Kurzeder, C., Elser, G. & Du Bois, A. 2013. Addition of vandetanib to pegylated liposomal doxorubicin (PLD) in patients with recurrent ovarian cancer. A randomized phase I/II study of the AGO Study Group (AGO-OVAR 2.13). Invest New Drugs, 31(6), 1499-504.
  • Heitz, F., Du Bois, A., Harter, P., Lubbe, D., Kurzeder, C., Vergote, I., Plante, M. & Pfisterer, J. 2013. Impact of beta blocker medication in patients with platinum sensitive recurrent ovarian cancer-a combined analysis of 2 prospective multicenter trials by the AGO Study Group, NCIC-CTG and EORTC-GCG. Gynecol Oncol, 129(3), 463-6.
  • Mahner, S., Eulenburg, C., Staehle, A., Wegscheider, K., Reuss, A., Pujade-Lauraine, E., Harter, P., Ray-Coquard, I., Pfisterer, J. & Du Bois, A. 2013. Prognostic impact of the time interval between surgery and chemotherapy in advanced ovarian cancer: analysis of prospective randomised phase III trials. Eur J Cancer, 49(1), 142-9.
  • Ohmann, C., Canham, S., Cornu, C., Dress, J., Gueyffier, F., Kuchinke, W., Nicolis, E. B. & Wittenberg, M. 2013. Revising the ECRIN standard requirements for information technology and data management in clinical trials. Trials, 1497.
  • Schuepbach, W. M. M., Rau, J., Knudsen, K., Volkmann, J., Krack, P., Timmermann, L., Hälbig, T. D., Hesekamp, H., Navarro, S. M., Meier, N., Falk, D., Mehdorn, M., Paschen, S., Maarouf, M., Barbe, M. T., Fink, G. R., Kupsch, A., Gruber, D., Schneider, G.-H., Seigneuret, E., Kistner, A., Chaynes, P., Ory-Magne, F., Brefel Courbon, C., Vesper, J., Schnitzler, A., Wojtecki, L., Houeto, J.-L., Bataille, B., Maltête, D., Damier, P., Raoul, S., Sixel-Doering, F., Hellwig, D., Gharabaghi, A., Krüger, R., Pinsker, M. O., Amtage, F., Régis, J.-M., Witjas, T., Thobois, S., Mertens, P., Kloss, M., Hartmann, A., Oertel, W. H., Post, B., Speelman, H., Agid, Y., Schade-Brittinger, C. & Deuschl, G. 2013. Neurostimulation for Parkinson's Disease with Early Motor Complications. New England Journal of Medicine, 368(7), 610-622.
  • Zipfel, S., Wild, B., Gross, G., Friederich, H. C., Teufel, M., Schellberg, D., Giel, K. E., De Zwaan, M., Dinkel, A., Herpertz, S., Burgmer, M., Lowe, B., Tagay, S., Von Wietersheim, J., Zeeck, A., Schade-Brittinger, C., Schauenburg, H. & Herzog, W. 2013. Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Lancet.

Publications 2012

  • 1. Deuschl G, Schüpbach M, Knudsen K, Pinsker MO, Cornu P, Rau J, Agid Y, Schade-Brittinger C. Stimulation ofthesubthalamicnucleusat an earlierdiseasestageofParkinson'sdisease: Conceptandstandardsofthe EARLYSTIM-study. ParkinsonismRelatDisord. 2012 Jul 28. [Epubaheadofprint].
  • 2. Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardière C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Müller HH, Skogseid B. CombinationChemotherapy in AdvancedAdrenocorticalCarcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97.
  • 3. Rosenow F, Schade-Brittinger C, Burchardi N, Bauer S, Klein KM, Weber Y, Lerche H, Evers S, Kovac S, Hallmeyer-Elgner S, Winkler G, Springub J, Niedhammer M, Roth E, Eisensehr I, Berrouschot J, Arnold S, Schröder M, Beige A, Oertel WH, Strzelczyk A, Haag A, Reif PS, Hamer HM; fortheLaLiMo Study Group. The LaLiMo Trial: lamotrigine compared with levetiracetam in the initial 26 weeks of monotherapy for focal and generalised epilepsy--an open-label, prospective, randomised controlled multicenter study.. J NeurolNeurosurg Psychiatry, Epub 2012 May 17.
  • 4. Harnisch S, Schade-Brittinger C, Rief W. Erfassung von Nebenwirkungen in der klinischen Forschung. Dtsch Med Wochenschr. 2012 Jul;137(27):1421-5.
  • 5. Meier W, du Bois A, Rau J, Gropp-Meier M, Baumann K, Huober J, Wollschlaeger K, Kreienberg R, Canzler U, Schmalfeldt B, Wimberger P, Richter B, Schröder W, Belau A, Stähle A, Burges A, Sehouli J. Randomizedphase II trialofcarboplatinandpaclitaxelwithorwithoutlonafarnib in first-linetreatmentofepithelialovariancancerstage IIB-IV. GynecolOncol. 2012 Aug;126(2):236-40.
  • 6. Wiegard K, Albert US, Zemlin C, Lubbe D, Kleiber C, Kolb-Niemann B, Schade-Brittinger C, Wagner U, Herrmann-Lingen C. Psychological distress of breast cancer patients: screening and patients' request for psycho-oncological care as indicators of health-related quality of life. PsychotherPsychosom Med Psychol. 2012 Mar-Apr;62(3-4):129-35. Epub 2012 Apr 2. German.
  • 7. Hanker LC, Loibl S, Burchardi N, Pfisterer J, Meier W, Pujade-Lauraine E, Ray-Coquard I, Sehouli J, Harter P, du Bois A; on behalf of the AGO and GINECO study group. The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/ platinum-based therapy. Ann Oncol. 2012 Aug 21. [Epub ahead of print]
  • 8. Baumann KH, du Bois A, Meier W, Rau J, Wimberger P, Sehouli J, Kurzeder C, Hilpert F, Hasenburg A, Canzler U, Hanker LC, Hillemanns P, Richter B, Wollschlaeger K, Dewitz T, Bauerschlag D, Wagner U. A phase II trial (AGO 2.11) in platinum-resistant ovarian ancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine inase inhibitor monotherapy. Ann Oncol. 2012 Sep;23(9):2265-71

Publications 2011

  • Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, et al. Prospective validation study of a predictive score for operability of recurrent ovarian cancer: the Multicenter Intergroup Study DESKTOP II. A project of the AGO Kommission OVAR, AGO Study Group, NOGGO, AGO-Austria, and MITO. Int J Gynecol Cancer 2011;21(2):289-95.
  • Larisch A, Reuss A, Oertel WH, Eggert K. Does the clinical practice guideline on Parkinson's disease change health outcomes? A cluster randomized controlled trial. J Neurol 2011;258(5):826-34.
  • Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, et al. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials 2011;12(1):85.
  • Stamelou M, Christ H, Reuss A, Oertel W, Hoglinger G. Hypodipsia discriminates progressive supranuclear palsy from other parkinsonian syndromes. Mov Disord 2011;26(5):901-5.

Publications 2010

  • Dodel R, Spottke A, Gerhard A, Reuss A, Reinecker S, Schimke N, et al. Minocycline 1-year therapy in multiple-system-atrophy: effect on clinical symptoms and [(11)C] (R)-PK11195 PET (MEMSA-trial). Mov Disord 2010;25(1):97-107.
  • du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, et al. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol 2010;28(27):4162-9.
  • du Bois A, Reuss A, Harter P, Pujade-Lauraine E, Ray-Coquard I, Pfisterer J. Potential role of lymphadenectomy in advanced ovarian cancer: a combined exploratory analysis of three prospectively randomized phase III multicenter trials. J Clin Oncol 2010;28(10):1733-9.
  • Köbel M, Reuss A, Bois A, Kommoss S, Kommoss F, Gao D, et al. The biological and clinical value of p53 expression in pelvic high-grade serous carcinomas. J Pathol 2010;222(2):191-8.
  • Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials 2010;11:79.
  • Mackay HJ, Brady MF, Oza AM, Reuss A, Pujade-Lauraine E, Swart AM, et al. Prognostic relevance of uncommon ovarian histology in women with stage III/IV epithelial ovarian cancer. Int J Gynecol Cancer 2010;20(6):945-52.
  • Menzler K, Chen X, Thiel P, Iwinska-Zelder J, Miller D, Reuss A, et al. Epileptogenicity of cavernomas depends on (archi-) cortical localization. Neurosurgery 2010;67(4):918-24.

Contact

KKS Marburg

Medizinische Fakultät
der Philipps-Universität Marburg
Karl-von-Frisch-Straße 4
35043 Marburg

Phone: 06421 286 6509
Fax: 06421 286 6517
info@kks.uni-marburg.de

http://www.kks.uni-marburg.de


Facts

about the KKS Marburg

  • Director
    Carmen Schade-Brittinger
    carmen.brittinger(at)kks.uni-marburg.de
  • Foundation
    2000 by the Medical Faculty
  • Funding
    German Federal Ministry of Education and Research from 2000 to 2006
  • Members of the KKS-Network
    Since 1999 (funding period)
  • Staff development
    10 members of staff in 2000
    30 members of staff in 2011
  • Main focus
    Oncology, neurology, neurosurgery, surgery, orthopaedics, cardiology
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