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Trial Title: The PLATON Network

NCT ID: NCT05489250

Condition: Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer

Conditions: Official terms:
Pancreatic Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Stomach Neoplasms
Liver Neoplasms
Carcinoma, Hepatocellular

Conditions: Keywords:
Gastric cancer
Individualized cancer therapy
Targetable mutations
NGS
Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Platform-Design
Biobanking

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
The PLATON Network and its associated pilot study (clinicaltrials.gov:. NCT04484636) enrolls national-wide participants of both sexes and ages over 18 years. All participants are patients diagnosed with hepatocellular cancer (HCC) or intra-/extrahepatic cholangiocellular carcinoma (CCA) or gallbladder carcinoma (GBCA) or pancreatic cancer (PanCa) or esophagogastric cancer (EC/GC). At the time of enrolment life expectancy is at least 6 months and no local curative therapy is available.

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

Locations:

Facility:
Name: KHNW Frankfurt

Address:
City: Frankfurt
Zip: 60488
Country: Germany

Status: Recruiting

Contact:
Last name: Thorsten Götze, Prof.

Contact backup:
Last name: Ulli Bankstahl

Investigator:
Last name: Thorsten Götze, Prof.
Email: Principal Investigator

Investigator:
Last name: Timursah Habibzade, Dr.
Email: Sub-Investigator

Facility:
Name: Friedrich-Ebert-Krankenhaus Neumünster

Address:
City: Neumünster
Zip: 24534
Country: Germany

Status: Recruiting

Contact:
Last name: Siegfried Haas, Dr.

Contact backup:
Last name: Stefan Mahlmann, Dr.

Investigator:
Last name: Kristin Bajorat
Email: Sub-Investigator

Investigator:
Last name: Paul Zimmermann, Dr.
Email: Sub-Investigator

Investigator:
Last name: Karsten Hamann, Dr.
Email: Sub-Investigator

Facility:
Name: HELIOS Klinikum Bad Saarow

Address:
City: Bad Saarow
Country: Germany

Status: Recruiting

Contact:
Last name: Daniel Pink, Dr. med.

Contact backup:
Last name: Simone Micheel

Facility:
Name: Evangelisches Waldkrankenhaus Spandau

Address:
City: Berlin
Country: Germany

Status: Recruiting

Contact:
Last name: Silke Polata, Dr

Contact backup:
Last name: Ute Moritz

Investigator:
Last name: Silke Polata, Dr.
Email: Principal Investigator

Investigator:
Last name: Kristin Lindemann, Dr.
Email: Sub-Investigator

Facility:
Name: MVZ Oskar-Helene-Heim Berlin

Address:
City: Berlin
Country: Germany

Status: Recruiting

Contact:
Last name: Markus Schuler, Dr. med.

Contact backup:
Last name: Leffers Elvira

Investigator:
Last name: Markus Schuler, Dr. med.
Email: Principal Investigator

Investigator:
Last name: Philipp Kiewe, Dr. med.
Email: Sub-Investigator

Facility:
Name: Augusta-Kranken-Anstalt Bochum

Address:
City: Bochum
Country: Germany

Status: Recruiting

Contact:
Last name: Dirk Behringer, Prof. Dr.

Contact backup:
Last name: Dorothee Henzler

Investigator:
Last name: Dirk Behringer, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Annette Nolte, Dr.
Email: Sub-Investigator

Investigator:
Last name: Iris Dieck-Stiller
Email: Sub-Investigator

Investigator:
Last name: Anna E Zdebik
Email: Sub-Investigator

Investigator:
Last name: Tanja Woiwod
Email: Sub-Investigator

Investigator:
Last name: Stefan Lukic
Email: Sub-Investigator

Facility:
Name: Bochum Uni

Address:
City: Bochum
Country: Germany

Status: Recruiting

Contact:
Last name: Michael Pohl, Dr.

Contact backup:
Last name: Julia Buß

Investigator:
Last name: Michael Pohl, Dr.
Email: Principal Investigator

Investigator:
Last name: Deepak Vangala, Dr.
Email: Sub-Investigator

Facility:
Name: Klinikum Chemnitz

Address:
City: Chemnitz
Country: Germany

Status: Recruiting

Contact:
Last name: Jack Chater, Dr.

Contact backup:
Last name: Katja Schaarschmidt

Investigator:
Last name: Jack Chater, Dr.
Email: Principal Investigator

Investigator:
Last name: Hagen Rudolph, Dr.
Email: Sub-Investigator

Investigator:
Last name: Ilja Kubisch, Dr.
Email: Sub-Investigator

Facility:
Name: GEFOS - Gesellschaft für onkologische Studien Dortmund

Address:
City: Dortmund
Country: Germany

Status: Recruiting

Contact:
Last name: Clemens Schulte, Dr.

Contact backup:
Last name: Monika Ludwig, Dr.

Investigator:
Last name: Clemens Schulte, Dr.
Email: Principal Investigator

Investigator:
Last name: Jörg Lipke, Dr.
Email: Sub-Investigator

Investigator:
Last name: Christiane Dr. Christiane Bernhardt, Dr.
Email: Sub-Investigator

Investigator:
Last name: Daniela Collette
Email: Sub-Investigator

Investigator:
Last name: Sandra Ketzler-Henkel
Email: Sub-Investigator

Facility:
Name: Onkozentrum Dresden

Address:
City: Dresden
Country: Germany

Status: Recruiting

Contact:
Last name: Steffen Dörfel

Contact backup:
Last name: Franziska Schwarzbach

Investigator:
Last name: Steffen Dörfel
Email: Principal Investigator

Investigator:
Last name: Thomas Göhler, Dr.
Email: Sub-Investigator

Investigator:
Last name: Sebastian Thiele, Dr.
Email: Principal Investigator

Investigator:
Last name: Susann Melzer, Dr.
Email: Sub-Investigator

Investigator:
Last name: Thomas Boldt
Email: Sub-Investigator

Facility:
Name: Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie

Address:
City: Essen
Zip: 45136
Country: Germany

Status: Recruiting

Contact:
Last name: Stefan Pluntke, MD

Investigator:
Last name: Stefan Pluntke, MD
Email: Principal Investigator

Facility:
Name: MVZ Onkologische Kooperation Harz

Address:
City: Goslar
Country: Germany

Status: Recruiting

Contact:
Last name: Mark-Oliver Zahn, Dr.

Contact backup:
Last name: Alexandra Hess

Investigator:
Last name: Mark-Oliver Zahn, Dr.
Email: Principal Investigator

Investigator:
Last name: Timo Kambach, Dr.
Email: Sub-Investigator

Investigator:
Last name: Bijan Zomorodbakhsch, Dr.
Email: Sub-Investigator

Investigator:
Last name: Martin Stolze, Dr.
Email: Sub-Investigator

Facility:
Name: Universitätsklinikum Halle (Saale)

Address:
City: Halle
Country: Germany

Status: Recruiting

Contact:
Last name: Patrick Michl, Prof. Dr.

Contact backup:
Last name: Susanne Behl

Investigator:
Last name: Patrick Michl, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Petra Büchner-Steudel
Email: Sub-Investigator

Investigator:
Last name: Sebastian Krug
Email: Sub-Investigator

Investigator:
Last name: Nora Schweitzer
Email: Sub-Investigator

Facility:
Name: Hamburg Onkologische Schwerpunktpraxis Eppendorf

Address:
City: Hamburg
Country: Germany

Status: Recruiting

Contact:
Last name: Eray Goekkurt

Contact backup:
Last name: Beate Poppinga-Scholz

Investigator:
Last name: Alexander Stein, Dr.
Email: Principal Investigator

Investigator:
Last name: Eray Goekkurt, Dr.
Email: Principal Investigator

Facility:
Name: St. Anna Hospital Herne

Address:
City: Herne
Country: Germany

Status: Recruiting

Contact:
Last name: Vera Heuer, Dr.

Contact backup:
Last name: Monika Stache

Investigator:
Last name: Vera Heuer, Dr.
Email: Principal Investigator

Investigator:
Last name: Christoph Dobrescu
Email: Sub-Investigator

Investigator:
Last name: Tjorven K Förster
Email: Sub-Investigator

Investigator:
Last name: Philipp J Haubold
Email: Sub-Investigator

Investigator:
Last name: Martin Jazra, Dr.
Email: Sub-Investigator

Investigator:
Last name: Viktor Rempel, Dr.
Email: Sub-Investigator

Facility:
Name: Ortenau Klinikum Lahr-Ettenheim

Address:
City: Lahr
Country: Germany

Status: Recruiting

Contact:
Last name: Jean-Charles Moulin, Dr.

Contact backup:
Last name: Kerstin Riedel

Investigator:
Last name: Jean-Charles Moulin, Dr.
Email: Principal Investigator

Investigator:
Last name: Oliver Delic, Dr.
Email: Sub-Investigator

Investigator:
Last name: Angela Nieder, Dr.
Email: Sub-Investigator

Investigator:
Last name: Oliver Schmah, Dr.
Email: Sub-Investigator

Facility:
Name: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH

Address:
City: Landshut
Country: Germany

Status: Recruiting

Contact:
Last name: Michael Sohm, Dr.

Contact backup:
Last name: Ana Hoffmann, Dr.

Investigator:
Last name: Michael Sohm, Dr.
Email: Principal Investigator

Investigator:
Last name: Ursula Vehling-Kaiser, Dr.
Email: Sub-Investigator

Investigator:
Last name: Florian Kaiser, Dr.
Email: Sub-Investigator

Investigator:
Last name: Franziskus Finsterwalder, Dr.
Email: Sub-Investigator

Investigator:
Last name: Mike Haberkorn
Email: Sub-Investigator

Investigator:
Last name: Maximilian Müller, Dr.
Email: Sub-Investigator

Facility:
Name: Langen, Gemeinschaftspraxis für Hämatologie und Onkologie

Address:
City: Langen
Country: Germany

Status: Recruiting

Contact:
Last name: Andreas Köhler, Dr.

Contact backup:
Last name: Beate Jung

Investigator:
Last name: Andreas Köhler, Dr.
Email: Principal Investigator

Investigator:
Last name: Roswitha Fuchs, Dr.
Email: Sub-Investigator

Investigator:
Last name: Katharina Girod, Dr.
Email: Sub-Investigator

Facility:
Name: Studienzentrum UnterEms

Address:
City: Leer
Country: Germany

Status: Recruiting

Contact:
Last name: Lothar Müller, Dr.

Contact backup:
Last name: Christine Strohschnieder

Investigator:
Last name: Lothar Müller, Dr.
Email: Principal Investigator

Facility:
Name: Klinikum Lippe

Address:
City: Lemgo
Country: Germany

Status: Recruiting

Contact:
Last name: Frank Hartmann, Prof. Dr.

Contact backup:
Last name: Melanie Kriete

Investigator:
Last name: Frank Hartmann, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Christian Constantin, Dr.
Email: Sub-Investigator

Investigator:
Last name: Sarunas Bagdonas, Dr.
Email: Sub-Investigator

Facility:
Name: Klinikum Ludwigsburg

Address:
City: Ludwigsburg
Country: Germany

Status: Recruiting

Contact:
Last name: Stefan Angermeier, Dr.

Contact backup:
Last name: Juliane Behn

Investigator:
Last name: Stefan Angermeier, Dr.
Email: Principal Investigator

Investigator:
Last name: Matthias Ulmer, Dr.
Email: Sub-Investigator

Facility:
Name: Klinik München-Bogenhausen

Address:
City: München
Country: Germany

Status: Recruiting

Contact:
Last name: Martin Fuchs, Dr.

Contact backup:
Last name: Bettina Huß

Investigator:
Last name: Martin Fuchs, Dr.
Email: Principal Investigator

Investigator:
Last name: Irene Klingenberg, Dr.
Email: Sub-Investigator

Investigator:
Last name: Jael Nisenbaum, Dr.
Email: Sub-Investigator

Investigator:
Last name: Fabian Hartmann, Dr.
Email: Sub-Investigator

Facility:
Name: Münster, Gemeinschaftspraxis für Hämatologie und Onkologie

Address:
City: Münster
Country: Germany

Status: Recruiting

Contact:
Last name: Rüdiger Liersch, Dr.

Contact backup:
Last name: Martina Ester

Investigator:
Last name: Rüdiger Liersch, Dr.
Email: Principal Investigator

Investigator:
Last name: Christian Lerchenüller, Dr.
Email: Sub-Investigator

Investigator:
Last name: Ralf Bieker, Dr.
Email: Sub-Investigator

Investigator:
Last name: Karsten Kratz-Albers, Dr.
Email: Sub-Investigator

Investigator:
Last name: Holger Timmer, Dr.
Email: Sub-Investigator

Investigator:
Last name: Daniela Schüler, Dr.
Email: Sub-Investigator

Facility:
Name: Medius Klinik Osterfildern-Ruit

Address:
City: Ostfildern
Country: Germany

Status: Recruiting

Contact:
Last name: Bodo Klump, Prof. Dr.

Contact backup:
Last name: Chistine Neumann

Investigator:
Last name: Bodo Klump, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Alberta-May Daraban-Brixner, Dr.
Email: Sub-Investigator

Investigator:
Last name: Nikolai Schuelper, Dr.
Email: Sub-Investigator

Investigator:
Last name: Karin Waibel, Dr.
Email: Sub-Investigator

Facility:
Name: Krankenhaus Barmherzige Brüder

Address:
City: Regensburg
Country: Germany

Status: Recruiting

Contact:
Last name: Nicolas Moosmann, Dr.

Contact backup:
Last name: Christiane Reinert

Investigator:
Last name: Nicolas Moosmann, Dr.
Email: Principal Investigator

Investigator:
Last name: Anke Schlenska-Lange, Dr.
Email: Sub-Investigator

Investigator:
Last name: Nadia Maguire, Dr.
Email: Sub-Investigator

Investigator:
Last name: V. Berberich, Dr.
Email: Sub-Investigator

Investigator:
Last name: Jan Braess, Prof. Dr.
Email: Sub-Investigator

Investigator:
Last name: Susanne Thalmeier, Dr.
Email: Sub-Investigator

Investigator:
Last name: Heribert Stauder, Dr.
Email: Sub-Investigator

Investigator:
Last name: Michael Schenk, Dr.
Email: Sub-Investigator

Investigator:
Last name: Bernhard Heilmeier, Dr.
Email: Sub-Investigator

Investigator:
Last name: Bernard Braun, Dr.
Email: Sub-Investigator

Facility:
Name: Klinikum Rheine, Mathias-Spital Rheine

Address:
City: Rheine
Country: Germany

Status: Recruiting

Contact:
Last name: Sebastian Broeckling, Dr.

Contact backup:
Last name: Kerstin Vehring

Investigator:
Last name: Sebastian Broeckling, Dr.
Email: Principal Investigator

Investigator:
Last name: Stefan Zicholl, Dr.
Email: Sub-Investigator

Investigator:
Last name: Antonia Hansmeier, Dr.
Email: Sub-Investigator

Investigator:
Last name: Guido Bisping, Dr.
Email: Sub-Investigator

Facility:
Name: CaritasKlinikum Saarbrücken

Address:
City: Saarbrücken
Country: Germany

Status: Recruiting

Contact:
Last name: Manfred Lutz, Prof. Dr.

Contact backup:
Last name: Ulrike Schilling

Investigator:
Last name: Manfred Lutz, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Michael Clemens, Prof. Dr.
Email: Sub-Investigator

Investigator:
Last name: Anca A Cura, Dr.
Email: Sub-Investigator

Investigator:
Last name: Jérôme Schwingel
Email: Sub-Investigator

Facility:
Name: Onkologie Bodensee

Address:
City: Singen
Country: Germany

Status: Recruiting

Contact:
Last name: Thomas Fietz, Dr.

Contact backup:
Last name: Karin Kingerter

Investigator:
Last name: Thomas Fietz, Dr.
Email: Principal Investigator

Investigator:
Last name: Christian Hertkorn, Dr.
Email: Sub-Investigator

Investigator:
Last name: Niels Steinebrunner, Dr.
Email: Sub-Investigator

Facility:
Name: Marien Hospital Witten

Address:
City: Witten
Country: Germany

Status: Recruiting

Contact:
Last name: Matthias Zeth, Dr.

Contact backup:
Last name: Katja Fritz

Investigator:
Last name: Matthias Zeth, Dr.
Email: Principal Investigator

Investigator:
Last name: Metin Senkal, Prof. Dr.
Email: Sub-Investigator

Facility:
Name: Klinikum Wolfsburg

Address:
City: Wolfsburg
Country: Germany

Status: Recruiting

Contact:
Last name: Nils Homann, Prof. Dr.

Contact backup:
Last name: Jeannette Wertmann

Investigator:
Last name: Nils Homann, Prof. Dr.
Email: Principal Investigator

Investigator:
Last name: Steffen Neumann, Dr.
Email: Sub-Investigator

Investigator:
Last name: Janine Markgraf
Email: Sub-Investigator

Investigator:
Last name: Alexander Behrens, Dr.
Email: Sub-Investigator

Investigator:
Last name: Ulrike Weber
Email: Sub-Investigator

Facility:
Name: Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH

Address:
City: Wolfsburg
Country: Germany

Status: Recruiting

Contact:
Last name: Thomas Gabrysiak, Dr.

Contact backup:
Last name: Carina Kupke

Investigator:
Last name: Thomas Gabrysiak, Dr.
Email: Principal Investigator

Investigator:
Last name: Joachim Haessner, Dr.
Email: Sub-Investigator

Investigator:
Last name: Katrin Heine, Dr.
Email: Sub-Investigator

Investigator:
Last name: Jens Kersten
Email: Sub-Investigator

Start date: October 28, 2020

Completion date: May 31, 2032

Lead sponsor:
Agency: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Agency class: Other

Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05489250
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