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Spots Global Cancer Trial Database for PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

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