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Center for Clinical Studies

 
Krista Stoycheva
+49 4537 / 188-3711, 8080
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Das Studienzentrum ist die Schnittstelle zwischen Grundlagenwissenschaft und Patientenversorgung in der Klinik und dem angegliederten Versorgungszentrum. Unsere Expertise liegt in der Planung, Organisation und Durchführung klinischer Studien. Unser Spektrum umfasst translationale Forschungsprojekte in enger Kooperation mit Grundlagenwissenschaftlern, Verbundstudien pneumologischer und infektiologischer Fachverbände und Arzneimittelstudien der pharmazeutischen Industrie.

Unser Fokus sind übertragbare und nicht-übertragbare Erkrankungen der Atemwege. Ein Schwerpunkt ist die klinische Tuberkuloseforschung. Andere Studien betreffen Asthma, Allergie, COPD, Pneumonie, Weaning und andere pneumologische Erkrankungen. Zudem führen wir onkologische Studien durch.

 

 

For further information please visit our website sz.fz-borstel.de


The Center for Clinical Studies Borstel has three main focuses: translational research, diagnostic or biomolecular investigations on clinical biomaterials and trials according to German Medicine Act (Arzneimittelgesetz, AMG) on therapeutic compounds (phases I - IV). On the on hand, the laboratory infrastructure in Borstel facilitates rapid access to clinical and research laboratories on the campus. On the other hand, our close proximity to the hospital wards and the outpatient department of the “Medizinische Klinik” allows easy recruitment of ambulatory and bed-bound patients for clinical research.

Based on this closely woven connection between basic research, laboratories and patient management, we can offer a wide spectrum of resources and options that can be used for scientific purposes. More details about our facilities and staff can be found here. Subsequently, we offer a wide range of services: planning, layout and conduct of Investigator Initiated Trials, conceptual design of study protocols, consultant services for sponsors, CRO / SMO services for sponsors of industry driven projects, etc. Please visit the following sites for further details.

 

Know-how

 

Pre-study
  • Conceptual design of clinical trials
  • Statistical estimations
  • Budget calculations
  • Creation of study protocols
  • CRF design
  • Communication with the Ethics Committee

 

During the study
  • Conduct of clinical trials according to ICH-GCP
  • Screening and recruiting of participants
  • Professional data acquisition and documentation
  • Serious Adverse Events (SAE) and Unexpected Adverse Events (UAE) Management
  • Cooperation and support for external monitors and CRAs

 

Post-study
  • Data storage
  • Statistical analysis
  • Writing of reports
  • Support and consultant services for publications

 

2023

Hamada, Y, Gupta, RK, Quartagno, M, Izzard, A, Acuna-Villaorduna, C, Altet, N, Diel, R, Dominguez, J, Floyd, S, Gupta, A, Huerga, H, Jones-López, EC, Kinikar, A, Lange, C, van Leth, F, Liu, Q, Lu, W, Lu, P, Rueda, IL, Martinez, L, Mbandi, SK, Muñoz, L, Padilla, ES, Paradkar, M, Scriba, T, Sester, M, Shanaube, K, Sharma, SK, Sloot, R, Sotgiu, G, Thiruvengadam, K, Vashishtha, R, Abubakar, I & Rangaka, MX 2023, 'Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis', EClinicalMedicine, Jg. 56, S. 101815. https://doi.org/10.1016/j.eclinm.2022.101815

Lange, C, Köhler, N & Günther, G 2023, 'Regimens for Drug-Resistant Tuberculosis', New England Journal of Medicine, Jg. 388, Nr. 2, S. 189-191. https://doi.org/10.1056/NEJMc2213970

Vierbuchen, T, Agarwal, S, Johnson, JL, Galia, L, Lei, X, Stein, K, Olagnier, D, Gaede, KI, Herzmann, C, Holm, CK, Heine, H, Pai, A, O'Hara Hall, A, Hoebe, K & Fitzgerald, KA 2023, 'The lncRNA LUCAT1 is elevated in inflammatory disease and restrains inflammation by regulating the splicing and stability of NR4A2', PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, Jg. 120, Nr. 1, S. e2213715120. https://doi.org/10.1073/pnas.2213715120

 

2022

Alter, P, Kahnert, K, Trudzinski, FC, Bals, R, Watz, H, Speicher, T, Söhler, S, Andreas, S, Welte, T, Rabe, KF, Wouters, EFM, Sassmann-Schweda, A, Wirtz, H, Ficker, JH, Vogelmeier, CF & Jörres, RA 2022, 'Disease Progression and Age as Factors Underlying Multimorbidity in Patients with COPD: Results from COSYCONET', International journal of chronic obstructive pulmonary disease, Jg. 17, S. 1703-1713. https://doi.org/10.2147/COPD.S364812

Brandenburg, J, Heyckendorf, J, Marwitz, F, Zehethofer, N, Linnemann, L, Gisch, N, Karaköse, H, Reimann, M, Kranzer, K, Kalsdorf, B, Sanchez-Carballo, P, Weinkauf, M, Scholz, V, Malm, S, Homolka, S, Gaede, KI, Herzmann, C, Schaible, UE, Hölscher, C, Reiling, N & Schwudke, D 2022, 'Tuberculostearic Acid-Containing Phosphatidylinositols as Markers of Bacterial Burden in Tuberculosis', ACS infectious diseases, Jg. 8, Nr. 7, S. 1303-1315. https://doi.org/10.1021/acsinfecdis.2c00075

Chesov, E, Chesov, D, Maurer, FP, Andres, S, Utpatel, C, Barilar, I, Donica, A, Reimann, M, Niemann, S, Lange, C, Crudu, V, Heyckendorf, J & Merker, M 2022, 'Emergence of bedaquiline resistance in a high tuberculosis burden country', The European respiratory journal, Jg. 59, Nr. 3, 2100621. https://doi.org/10.1183/13993003.00621-2021

Freundt, K, Herzmann, C, Biedziak, D, Scheffzük, C, Gaede, KI & Stamme, C 2022, 'Surfactant protein A enhances the degradation of LPS-induced TLR4 in primary alveolar macrophages involving Rab7, β-arrestin2, and mTORC1', INFECTION AND IMMUNITY , Jg. 90, Nr. 2, S. e0025021. https://doi.org/10.1128/IAI.00250-21

Lüthgen, M, Rüller, S & Herzmann, C 2022, 'Characteristics of the deventilation syndrome in COPD patients treated with non-invasive ventilation: an explorative study', RESPIRATORY RESEARCH , Jg. 23, Nr. 1, S. 13. https://doi.org/10.1186/s12931-022-01924-y

 

Head

 
Krista Stoycheva
+49 4537 / 188-3711, 8080
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Scientific staff

 
Johanna Döhling
+49 4537 / 188-3170, 8080
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Andrea Glaewe
+49 4537 / 188-6361, 8080
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Lenka Krabbe
+49 4537 / 188-7060, 8080
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Last Update: 11.01.2024