The PLATON Network

The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)

Sponsors

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Brief Summary

The PLATON Network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. Hereby, PLATON's study-design focuses on the patient's tumor molecular profiling. Within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at PLATON's study sites.

Detailed Description

The PLATON Network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. The study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects. Within PLATON results of genetic tests of different research projects like the PLATON pilot-study (NCT04484636) as well as Next-generation deep sequencing (NGS) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (TMB) and microsatellite instability (MSI). The PLATON Network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. Therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. The feasibility of this approach will be tested in the PLATON Network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.

Overall Status Recruiting
Start Date 2020-10-28
Completion Date 2032-05-31
Primary Completion Date 2032-05-31
Study Type Observational
Primary Outcome
Measure Time Frame
Frequency of targetable mutations in gastrointestinal cancer patients annual interim-analysis (1 year)
Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients annual interim-analysis (1 year)
Secondary Outcome
Measure Time Frame
Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients annual interim-analysis (1 year)
QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients annual interim-analysis (1 year)
QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients annual interim-analysis (1 year)
QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients annual interim-analysis (1 year)
QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients annual interim-analysis (1 year)
QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients annual interim-analysis (1 year)
QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients annual interim-analysis (1 year)
Enrollment 1000
Condition
Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - Histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available - Standard first line therapy is planned, or patient is currently receiving first-line therapy - Available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study - ECOG 0-2 - Life expectancy ≥ 6 months Exclusion Criteria: - Not able to understand all implications of study participation - No written informed consent - Age < 18 years

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Salah-Eddin Al-Batran, Prof. Dr.

Phone: +49 (0)69-7601-4420

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
KHNW Frankfurt | Frankfurt, Hessen, 60488, Germany Recruiting Salah-Eddin Al-Batran, Prof. Salah-Eddin Al-Batran, Prof. Principal Investigator Thorsten Götze, Prof. Principal Investigator Timursah Habibzade, Dr. Sub-Investigator
Friedrich-Ebert-Krankenhaus Neumünster | Neumünster, Schleswig-Holstein, 24534, Germany Recruiting Siegfried Haas, Dr. Kristin Bajorat Sub-Investigator Paul Zimmermann, Dr. Sub-Investigator Karsten Hamann, Dr. Sub-Investigator
HELIOS Klinikum Bad Saarow | Bad Saarow, Germany Recruiting Daniel Pink, Dr. med.
Evangelisches Waldkrankenhaus Spandau | Berlin, Germany Recruiting Silke Polata, Dr Silke Polata, Dr. Principal Investigator Kristin Lindemann, Dr. Sub-Investigator
MVZ Oskar-Helene-Heim Berlin | Berlin, Germany Recruiting Markus Schuler, Dr. med. Markus Schuler, Dr. med. Principal Investigator Philipp Kiewe, Dr. med. Sub-Investigator
Augusta-Kranken-Anstalt Bochum | Bochum, Germany Recruiting Dirk Behringer, Prof. Dr. Dirk Behringer, Prof. Dr. Principal Investigator Annette Nolte, Dr. Sub-Investigator Iris Dieck-Stiller Sub-Investigator Anna E Zdebik Sub-Investigator Tanja Woiwod Sub-Investigator Stefan Lukic Sub-Investigator
Bochum Uni | Bochum, Germany Recruiting Michael Pohl, Dr. Michael Pohl, Dr. Principal Investigator Deepak Vangala, Dr. Sub-Investigator
Klinikum Chemnitz | Chemnitz, Germany Recruiting Jack Chater, Dr. Jack Chater, Dr. Principal Investigator Hagen Rudolph, Dr. Sub-Investigator Ilja Kubisch, Dr. Sub-Investigator
GEFOS - Gesellschaft für onkologische Studien Dortmund | Dortmund, Germany Recruiting Clemens Schulte, Dr. Clemens Schulte, Dr. Principal Investigator Jörg Lipke, Dr. Sub-Investigator Christiane Dr. Christiane Bernhardt, Dr. Sub-Investigator Daniela Collette Sub-Investigator Sandra Ketzler-Henkel Sub-Investigator
Onkozentrum Dresden | Dresden, Germany Recruiting Steffen Dörfel Steffen Dörfel Principal Investigator Thomas Göhler, Dr. Sub-Investigator Sebastian Thiele, Dr. Principal Investigator Susann Melzer, Dr. Sub-Investigator Thomas Boldt Sub-Investigator
Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie | Essen, 45136, Germany Recruiting Stefan Pluntke, MD Stefan Pluntke, MD Principal Investigator
MVZ Onkologische Kooperation Harz | Goslar, Germany Recruiting Mark-Oliver Zahn, Dr. Mark-Oliver Zahn, Dr. Principal Investigator Timo Kambach, Dr. Sub-Investigator Bijan Zomorodbakhsch, Dr. Sub-Investigator Martin Stolze, Dr. Sub-Investigator
Universitätsklinikum Halle (Saale) | Halle, Germany Recruiting Patrick Michl, Prof. Dr. Patrick Michl, Prof. Dr. Principal Investigator Petra Büchner-Steudel Sub-Investigator Sebastian Krug Sub-Investigator Nora Schweitzer Sub-Investigator
Hamburg Onkologische Schwerpunktpraxis Eppendorf | Hamburg, Germany Recruiting Eray Goekkurt Alexander Stein, Dr. Principal Investigator Eray Goekkurt, Dr. Principal Investigator
St. Anna Hospital Herne | Herne, Germany Recruiting Vera Heuer, Dr. Vera Heuer, Dr. Principal Investigator Christoph Dobrescu Sub-Investigator Tjorven K Förster Sub-Investigator Philipp J Haubold Sub-Investigator Martin Jazra, Dr. Sub-Investigator Viktor Rempel, Dr. Sub-Investigator
Ortenau Klinikum Lahr-Ettenheim | Lahr, Germany Recruiting Jean-Charles Moulin, Dr. Jean-Charles Moulin, Dr. Principal Investigator Oliver Delic, Dr. Sub-Investigator Angela Nieder, Dr. Sub-Investigator Oliver Schmah, Dr. Sub-Investigator
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH | Landshut, Germany Recruiting Michael Sohm, Dr. Michael Sohm, Dr. Principal Investigator Ursula Vehling-Kaiser, Dr. Sub-Investigator Florian Kaiser, Dr. Sub-Investigator Franziskus Finsterwalder, Dr. Sub-Investigator Mike Haberkorn Sub-Investigator Maximilian Müller, Dr. Sub-Investigator
Langen, Gemeinschaftspraxis für Hämatologie und Onkologie | Langen, Germany Recruiting Andreas Köhler, Dr. Andreas Köhler, Dr. Principal Investigator Roswitha Fuchs, Dr. Sub-Investigator Katharina Girod, Dr. Sub-Investigator
Studienzentrum UnterEms | Leer, Germany Recruiting Lothar Müller, Dr. Lothar Müller, Dr. Principal Investigator
Klinikum Lippe | Lemgo, Germany Recruiting Frank Hartmann, Prof. Dr. Frank Hartmann, Prof. Dr. Principal Investigator Christian Constantin, Dr. Sub-Investigator Sarunas Bagdonas, Dr. Sub-Investigator
Klinikum Ludwigsburg | Ludwigsburg, Germany Recruiting Stefan Angermeier, Dr. Stefan Angermeier, Dr. Principal Investigator Matthias Ulmer, Dr. Sub-Investigator
Klinik München-Bogenhausen | München, Germany Recruiting Martin Fuchs, Dr. Martin Fuchs, Dr. Principal Investigator Irene Klingenberg, Dr. Sub-Investigator Jael Nisenbaum, Dr. Sub-Investigator Fabian Hartmann, Dr. Sub-Investigator
Münster, Gemeinschaftspraxis für Hämatologie und Onkologie | Münster, Germany Recruiting Rüdiger Liersch, Dr. Rüdiger Liersch, Dr. Principal Investigator Christian Lerchenüller, Dr. Sub-Investigator Ralf Bieker, Dr. Sub-Investigator Karsten Kratz-Albers, Dr. Sub-Investigator Holger Timmer, Dr. Sub-Investigator Daniela Schüler, Dr. Sub-Investigator
Medius Klinik Osterfildern-Ruit | Ostfildern, Germany Recruiting Bodo Klump, Prof. Dr. Bodo Klump, Prof. Dr. Principal Investigator Alberta-May Daraban-Brixner, Dr. Sub-Investigator Nikolai Schuelper, Dr. Sub-Investigator Karin Waibel, Dr. Sub-Investigator
Krankenhaus Barmherzige Brüder | Regensburg, Germany Recruiting Nicolas Moosmann, Dr. Nicolas Moosmann, Dr. Principal Investigator Anke Schlenska-Lange, Dr. Sub-Investigator Nadia Maguire, Dr. Sub-Investigator V. Berberich, Dr. Sub-Investigator Jan Braess, Prof. Dr. Sub-Investigator Susanne Thalmeier, Dr. Sub-Investigator Heribert Stauder, Dr. Sub-Investigator Michael Schenk, Dr. Sub-Investigator Bernhard Heilmeier, Dr. Sub-Investigator Bernard Braun, Dr. Sub-Investigator
Klinikum Rheine, Mathias-Spital Rheine | Rheine, Germany Recruiting Sebastian Broeckling, Dr. Sebastian Broeckling, Dr. Principal Investigator Stefan Zicholl, Dr. Sub-Investigator Antonia Hansmeier, Dr. Sub-Investigator Guido Bisping, Dr. Sub-Investigator
CaritasKlinikum Saarbrücken | Saarbrücken, Germany Recruiting Manfred Lutz, Prof. Dr. Manfred Lutz, Prof. Dr. Principal Investigator Michael Clemens, Prof. Dr. Sub-Investigator Anca A Cura, Dr. Sub-Investigator Jérôme Schwingel Sub-Investigator
Onkologie Bodensee | Singen, Germany Recruiting Thomas Fietz, Dr. Thomas Fietz, Dr. Principal Investigator Christian Hertkorn, Dr. Sub-Investigator Niels Steinebrunner, Dr. Sub-Investigator
Marien Hospital Witten | Witten, Germany Recruiting Matthias Zeth, Dr. Matthias Zeth, Dr. Principal Investigator Metin Senkal, Prof. Dr. Sub-Investigator
Klinikum Wolfsburg | Wolfsburg, Germany Recruiting Nils Homann, Prof. Dr. Nils Homann, Prof. Dr. Principal Investigator Steffen Neumann, Dr. Sub-Investigator Janine Markgraf Sub-Investigator Alexander Behrens, Dr. Sub-Investigator Ulrike Weber Sub-Investigator
Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH | Wolfsburg, Germany Recruiting Thomas Gabrysiak, Dr. Thomas Gabrysiak, Dr. Principal Investigator Joachim Haessner, Dr. Sub-Investigator Katrin Heine, Dr. Sub-Investigator Jens Kersten Sub-Investigator
Location Countries

Germany

Verification Date

2022-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: HCC (Hepatocellular cancer)

Description: Hepatocellular cancer patients with NGS based molecular tumor profiling

Label: CCA/GBCA (Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer)

Description: Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer patients with NGS based molecular tumor profiling

Label: PanCa (Pancreatic cancer)

Description: Pancreatic cancer patients with NGS based molecular tumor profiling

Label: EC/GC (Oesophagogastric cancer)

Description: Oesophagogastric cancer patients with NGS based molecular tumor profiling

Acronym PLATON
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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