PLATON - Platform for Analyzing Targetable Tumor Mutations (pilot-study)
- Conditions
- Pancreatic CancerOesophageal CancerGallbladder CancerCholangiocarcinomaHepatocellular CancerStomach Cancer
- Interventions
- Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid
- Registration Number
- NCT04484636
- Lead Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Histologically confirmed diagnosis of hepatocellular carcinoma or intra-/extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting and no local curative therapy available.
- Standard first line therapy is planned, or patient is currently receiving first line therapy (started within the last 2 months before enrolment)
- ECOG 0-2
- Life expectancy ≥ 6 months
- Not able to understand all implications of study participation
- No written informed consent
- age < 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hepatocellular Cancer FoundationOne®CDx and FoundationOne®Liquid molecular profiling - hepatocellular cancer (HCC) Cholangiocarcinoma FoundationOne®CDx and FoundationOne®Liquid molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA) Oesophageal Cancer + Stomach Cancer FoundationOne®CDx and FoundationOne®Liquid molecular profiling - esophagogastric cancer (EC/GC) Gallbladder Cancer FoundationOne®CDx and FoundationOne®Liquid molecular profiling - gallbladder carcinoma (GBCA) Pancreatic Cancer FoundationOne®CDx and FoundationOne®Liquid molecular profiling - pancreatic cancer (PanCa)
- Primary Outcome Measures
Name Time Method Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer up to 4 weeks after biospecimen provision Relative frequency of targetable mutations (incl. TMB and MSI status) computed as the number of patients who harbors at least one mutation divided by the number of total patients in the pooled patient population.
- Secondary Outcome Measures
Name Time Method Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA up to 4 weeks after biospecimen provision Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA
Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group up to 4 weeks after biospecimen provision Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group
Number of patients receiving therapies in accordance to their genomic profiles up to 4 weeks after biospecimen provision Number of patients receiving therapies in accordance to their genomic profiles
Trial Locations
- Locations (46)
Onkologische Schwerpunktpraxis Speyer
🇩🇪Speyer, Rheinland-Pfalz, Germany
Elblandklinikum Riesa
🇩🇪Ried, Sachsen, Germany
Sana Kliniken Leipziger Land
🇩🇪Borna, Thüringen, Germany
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