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Brief Title: PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)
Official Title: PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) A Multicenter, Prospective, Cohort Study To Assess The Genomic Profiles And Associated Therapy Decision In Gastrointestinal Cancer
Study ID: NCT04484636
Brief Summary: PLATON (Platform for Analyzing Targetable Mutations) is a prospective, multicentre, observational cohort study with biobanking. In a first approach PLATON's pilot-study assesses genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen and EDTA-whole blood samples. The Study Protocol does not define any further medical intervention or evaluate the efficacy or safety of the treatment decision made by the investigator. Another important objective of PLATON's pilot project is to evaluate whether and how many patients are treated based on their genomic profiles.
Detailed Description: PLATON (Platform for Analyzing Targetable Mutations) is designed to improve personalized therapy for patients in different cancer entities, such as in hepatocellular cancer (HCC), intra- and extrahepatic cholangiocellular carcinoma (CCA), gallbladder carcinoma (GBCA), pancreatic cancer (PanCa) and esophagogastric cancer (EC/GC), and elevate the treatment guidance within its framework. The key to understand the mechanisms in initiation, progression and response to treatment of cancer is the data integration of genetic mutational signatures with medical and physiological data of diseased cohorts. PLATON is a prospective, multicentre, observational cohort study with biobanking and does not define any medical intervention or evaluate the efficacy or safety of the treatment decision made by the investigator.In a first approach PLATON's pilot-study assess genomic profiling in gastrointestinal cancer therapy and the frequencies of targetable mutations including Tumor Mutational Burden (TMB) and Microsatellite Instability Status (MSI), performing Next-generation deep sequencing (NGS) using the Foundation Medicine assays on tumor specimen and EDTA-whole blood samples. Another important objective of PLATON's pilot project is to evaluate whether and how many patients are treated based on their genomic profiles. The pilot-study starts with the national-wide enrolment of 200 participants of both sexes and ages over 18 at 40 german study sites. The long-term vision is to enable cancer patients to receive the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
KHNW Frankfurt, Frankfurt, Hessen, Germany
Hannover Medical School, Hannover, Niedersachsen, Germany
Friedrich-Ebert-Krankenhaus Neumünster, Neumünster, Schleswig-Holstein, Germany
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
Klinikum Bayreuth, Bayreuth, , Germany
Vivantes Klinikum Spandau, Berlin, , Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Evangelisches Waldkrankenhaus Spandau, Berlin, , Germany
MVZ Oskar-Helene-Heim Berlin, Berlin, , Germany
Augusta-Kranken-Anstalt Bochum, Bochum, , Germany
Bochum Uni, Bochum, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Klinikum Darmstadt, Darmstadt, , Germany
GEFOS - Gesellschaft für onkologische Studien Dortmund, Dortmund, , Germany
Onkozentrum Dresden, Dresden, , Germany
Klinikum Frankfurt Höchst, Frankfurt, , Germany
Klinikum Fulda, Fulda, , Germany
MVZ Onkologische Kooperation Harz, Goslar, , Germany
Universitätsklinikum Halle (Saale), Halle, , Germany
Hamburg Onkologisch-Hämatologische Schwerpunktpraxis, Hamburg, , Germany
Evangelisches Krankenhaus Hamm, Hamm, , Germany
St. Anna Hospital Herne, Herne, , Germany
Ortenau Klinikum Lahr-Ettenheim, Lahr, , Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH, Landshut, , Germany
Langen, Gemeinschaftspraxis für Hämatologie und Onkologie, Langen, , Germany
Studienzentrum UnterEms, Leer, , Germany
Klinikum Lippe, Lemgo, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Universitätsklinikum Giessen und Marburg GmbH, Marburg, , Germany
Klinik München-Bogenhausen, München, , Germany
Münster, Gemeinschaftspraxis für Hämatologie und Onkologie, Münster, , Germany
Niels-Stensen-Kliniken Osnabrück, Osnabrück, , Germany
Medius Klinik Osterfildern-Ruit, Ostfildern, , Germany
Krankenhaus Barmherzige Brüder, Regensburg, , Germany
Klinikum Rheine, Mathias-Spital Rheine, Rheine, , Germany
RoMed Klinikum Rosenheim, Rosenheim, , Germany
Klinikum Südstadt Rostock, Rostock, , Germany
CaritasKlinikum Saarbrücken, Saarbrücken, , Germany
Onkologie Bodensee, Singen, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH, Wiesbaden, , Germany
Marien Hospital Witten, Witten, , Germany
Klinikum Wolfsburg, Wolfsburg, , Germany
Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH, Wolfsburg, , Germany
Name: Salah-Eddin Al-Batran, Prof.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH
Role: STUDY_DIRECTOR
Name: Arndt Vogel, Prof.
Affiliation: Hannover Medical School
Role: PRINCIPAL_INVESTIGATOR