PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) (PLATON)

July 17, 2023 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid

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

Study Type

Interventional

Enrollment (Estimated)

400

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Arndt Vogel, Prof. Dr.
Phone Number: +4969-7601-4420
Email: vogela@me.com

Study Contact Backup

Name: Bianca Zäpf
Phone Number: +4969-7601-4636
Email: zaepf.bianca@ikf-khnw.de

Study Locations

Germany
- - Bad Saarow, Germany
    - Recruiting
    - Helios Klinikum Bad Saarow
    - Contact:
      
      Daniel Pink, Dr.
    - Principal Investigator:
      
      Daniel Pink, Dr.
    - Contact:
      
      Simone Micheel
    - Sub-Investigator:
      
      Janina Bertz-Lepel, Dr.
    - Sub-Investigator:
      
      Antje West, Dr.
  - Bayreuth, Germany, 95445
    - Recruiting
    - Klinikum Bayreuth
    - Contact:
      
      Alexander Kiani, Prof. Dr.
    - Contact:
      
      Nadine Zeitler
    - Principal Investigator:
      
      Alexander Kiani, Prof. Dr.
    - Sub-Investigator:
      
      Carla Dorn
    - Sub-Investigator:
      
      Martina Katzenberger
    - Sub-Investigator:
      
      Werner Kippes
    - Sub-Investigator:
      
      Viktor Martens
    - Sub-Investigator:
      
      Melanie Wiederseiner
    - Sub-Investigator:
      
      Urlah Mbour
  - Berlin, Germany
    - Recruiting
    - Charité - Universitätsmedizin Berlin
    - Contact:
      
      Dominik Modest, Prof. Dr.
    - Contact:
      
      Susanne Grüneberg
    - Principal Investigator:
      
      Dominik Modest, Prof. Dr.
    - Sub-Investigator:
      
      Sebastian Stintzing, Prof. Dr.
    - Sub-Investigator:
      
      Annika Kurreck, Dr.
  - Berlin, Germany, 13585
    - Recruiting
    - Vivantes Klinikum Spandau
    - Contact:
      
      Jan Eucker, Dr.
    - Contact:
      
      Juliane Skerra
    - Principal Investigator:
      
      Jan Eucker, Dr.
    - Sub-Investigator:
      
      Jörg-Christian Rath, Dr.
    - Sub-Investigator:
      
      Annegret Kunitz, Dr.
    - Sub-Investigator:
      
      Anna Kohlhaas, Dr.
  - Berlin, Germany
    - Recruiting
    - Evangelisches Waldkrankenhaus Spandau
    - Contact:
      
      Silke Polata, Dr
    - Contact:
      
      Ute Moritz
    - Principal Investigator:
      
      Silke Polata, Dr.
    - Sub-Investigator:
      
      Kristin Lindemann, Dr.
  - Berlin, Germany
    - Recruiting
    - MVZ Oskar-Helene-Heim Berlin
    - Contact:
      
      Markus Schuler, Dr. med.
    - Contact:
      
      Leffers Elvira
    - Principal Investigator:
      
      Markus Schuler, Dr. med.
    - Sub-Investigator:
      
      Philipp Kiewe, Dr. med.
  - Bochum, Germany
    - Recruiting
    - Augusta-Kranken-Anstalt Bochum
    - Contact:
      
      Dirk Behringer, Prof. Dr.
    - Contact:
      
      Dorothee Henzler
    - Principal Investigator:
      
      Dirk Behringer, Prof. Dr.
    - Sub-Investigator:
      
      Annette Nolte, Dr.
    - Sub-Investigator:
      
      Iris Dieck-Stiller
    - Sub-Investigator:
      
      Anna E Zdebik
    - Sub-Investigator:
      
      Tanja Woiwod
    - Sub-Investigator:
      
      Stefan Lukic
  - Bochum, Germany
    - Recruiting
    - Bochum Uni
    - Contact:
      
      Michael Pohl, Dr.
    - Contact:
      
      Julia Buß
    - Principal Investigator:
      
      Michael Pohl, Dr.
    - Sub-Investigator:
      
      Deepak Vangala, Dr.
  - Chemnitz, Germany
    - Recruiting
    - Klinikum Chemnitz
    - Contact:
      
      Jack Chater, Dr.
    - Contact:
      
      Katja Schaarschmidt
    - Principal Investigator:
      
      Jack Chater, Dr.
    - Sub-Investigator:
      
      Hagen Rudolph, Dr.
    - Sub-Investigator:
      
      Ilja Kubisch, Dr.
  - Darmstadt, Germany
    - Recruiting
    - Klinikum Darmstadt
    - Contact:
      
      Helga Bernhard, Prof. Dr.
    - Contact:
      
      Cora Schwebel-Kottke
    - Principal Investigator:
      
      Helga Bernhard, Prof. Dr.
    - Sub-Investigator:
      
      Rainer Schuker, Dr.
    - Sub-Investigator:
      
      Stephan Schäfer, Dr.
    - Sub-Investigator:
      
      Petra Dörner-Mann, Dr.
    - Sub-Investigator:
      
      Thorsten Wenzel, Dr.
    - Sub-Investigator:
      
      Corinna Gobst, Dr.
    - Sub-Investigator:
      
      Tu-Anh Dang, Dr.
  - Dortmund, Germany
    - Recruiting
    - GEFOS - Gesellschaft für onkologische Studien Dortmund
    - Contact:
      
      Clemens Schulte, Dr.
    - Contact:
      
      Monika Ludwig, Dr.
    - Principal Investigator:
      
      Clemens Schulte, Dr.
    - Sub-Investigator:
      
      Jörg Lipke, Dr.
    - Sub-Investigator:
      
      Christiane Dr. Christiane Bernhardt, Dr.
    - Sub-Investigator:
      
      Daniela Collette
    - Sub-Investigator:
      
      Sandra Ketzler-Henkel
  - Dresden, Germany
    - Recruiting
    - Onkozentrum Dresden
    - Contact:
      
      Steffen Dörfel
    - Contact:
      
      Franziska Schwarzbach
    - Principal Investigator:
      
      Steffen Dörfel
    - Sub-Investigator:
      
      Thomas Göhler, Dr.
    - Principal Investigator:
      
      Sebastian Thiele, Dr.
    - Sub-Investigator:
      
      Susann Melzer, Dr.
    - Sub-Investigator:
      
      Thomas Boldt
  - Frankfurt, Germany, 65929
    - Recruiting
    - Klinikum Frankfurt Höchst
    - Contact:
      
      Hans-Günter Derigs, Prof. Dr.
    - Contact:
      
      Kim-Cybil Hermann
    - Principal Investigator:
      
      Hans-Günter Derigs, Prof. Dr.
    - Sub-Investigator:
      
      Felicitas Scholten, Dr.
  - Fulda, Germany, 36043
    - Recruiting
    - Klinikum Fulda
    - Contact:
      
      Andreas Dickhut, Dr.
    - Contact:
      
      Christine Lochner
    - Principal Investigator:
      
      Andreas Dickhut, Dr.
    - Sub-Investigator:
      
      Philippe Kostrewa, Dr.
    - Sub-Investigator:
      
      Heinz-Gert Höffkes, Prof. Dr.
    - Sub-Investigator:
      
      Ulrich Bonse-Geuking, Dr.
  - Goslar, Germany
    - Recruiting
    - MVZ Onkologische Kooperation Harz
    - Contact:
      
      Mark-Oliver Zahn, Dr.
    - Contact:
      
      Alexandra Hess
    - Principal Investigator:
      
      Mark-Oliver Zahn, Dr.
    - Sub-Investigator:
      
      Timo Kambach, Dr.
    - Sub-Investigator:
      
      Bijan Zomorodbakhsch, Dr.
    - Sub-Investigator:
      
      Martin Stolze, Dr.
  - Halle, Germany
    - Recruiting
    - Universitatsklinikum Halle (Saale)
    - Contact:
      
      Susanne Behl
    - Sub-Investigator:
      
      Sebastian Krug
    - Sub-Investigator:
      
      Nora Schweitzer
    - Contact:
      
      Petra Büchner-Steudel, Dr.
    - Principal Investigator:
      
      Petra Büchner-Steudel, Dr.
  - Hamburg, Germany, 22457
    - Recruiting
    - Hamburg Onkologisch-Hämatologische Schwerpunktpraxis
    - Contact:
      
      Tobias Graefe
    - Contact:
      
      Mona Porep
    - Principal Investigator:
      
      Tobias Graefe
    - Sub-Investigator:
      
      Stefan Bonmann, Dr.
    - Sub-Investigator:
      
      Kristine Hochgartz, Dr.
    - Sub-Investigator:
      
      Christine Lange-Hüsken
    - Sub-Investigator:
      
      Sigrun Müller-Hagen, Dr.
    - Sub-Investigator:
      
      Torsten Winterberg, Dr.
  - Hamm, Germany, 59063
    - Recruiting
    - Evangelisches Krankenhaus Hamm
    - Contact:
      
      Alexander Baraniskin, Prof. Dr.
    - Contact:
      
      Claudia Pospiech
    - Principal Investigator:
      
      Alexander Baraniskin, Prof. Dr.
    - Sub-Investigator:
      
      Ruxandra Elena Parascan, Dr.
    - Sub-Investigator:
      
      Marina Dreglea
    - Sub-Investigator:
      
      Andrea Stoltefuß
  - Herne, Germany
    - Recruiting
    - St. Anna Hospital Herne
    - Contact:
      
      Vera Heuer, Dr.
    - Contact:
      
      Monika Stache
    - Principal Investigator:
      
      Vera Heuer, Dr.
    - Sub-Investigator:
      
      Christoph Dobrescu
    - Sub-Investigator:
      
      Tjorven K Förster
    - Sub-Investigator:
      
      Philipp J Haubold
    - Sub-Investigator:
      
      Martin Jazra, Dr.
    - Sub-Investigator:
      
      Viktor Rempel, Dr.
  - Lahr, Germany
    - Recruiting
    - Ortenau Klinikum Lahr-Ettenheim
    - Contact:
      
      Jean-Charles Moulin, Dr.
    - Contact:
      
      Kerstin Riedel
    - Principal Investigator:
      
      Jean-Charles Moulin, Dr.
    - Sub-Investigator:
      
      Oliver Delic, Dr.
    - Sub-Investigator:
      
      Angela Nieder, Dr.
    - Sub-Investigator:
      
      Oliver Schmah, Dr.
  - Landshut, Germany
    - Recruiting
    - ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
    - Sub-Investigator:
      
      Mike Haberkorn
    - Sub-Investigator:
      
      Franziskus Finsterwalder, Dr.
    - Contact:
      
      Michael Sohm, Dr.
    - Contact:
      
      Ana Hoffmann, Dr.
    - Principal Investigator:
      
      Michael Sohm, Dr.
    - Sub-Investigator:
      
      Ursula Vehling-Kaiser, Dr.
    - Sub-Investigator:
      
      Florian Kaiser, Dr.
    - Sub-Investigator:
      
      Maximilian Müller, Dr.
  - Langen, Germany
    - Recruiting
    - Langen, Gemeinschaftspraxis für Hämatologie und Onkologie
    - Contact:
      
      Andreas Köhler, Dr.
    - Contact:
      
      Beate Jung
    - Principal Investigator:
      
      Andreas Köhler, Dr.
    - Sub-Investigator:
      
      Roswitha Fuchs, Dr.
    - Sub-Investigator:
      
      Katharina Girod, Dr.
  - Leer, Germany
    - Recruiting
    - Studienzentrum UnterEms
    - Contact:
      
      Lothar Müller, Dr.
    - Contact:
      
      Christine Strohschnieder
    - Principal Investigator:
      
      Lothar Müller, Dr.
  - Lemgo, Germany
    - Recruiting
    - Klinikum Lippe
    - Principal Investigator:
      
      Frank Hartmann, Prof. Dr.
    - Contact:
      
      Frank Hartmann, Prof. Dr.
    - Contact:
      
      Melanie Kriete
    - Sub-Investigator:
      
      Christian Constantin, Dr.
    - Sub-Investigator:
      
      Sarunas Bagdonas, Dr.
  - Ludwigsburg, Germany
    - Recruiting
    - Klinikum Ludwigsburg
    - Contact:
      
      Stefan Angermeier, Dr.
    - Contact:
      
      Juliane Behn
    - Principal Investigator:
      
      Stefan Angermeier, Dr.
    - Sub-Investigator:
      
      Matthias Ulmer, Dr.
  - Marburg, Germany, 35043
    - Recruiting
    - Universitatsklinikum Gießen und Marburg GmbH
    - Contact:
      
      Anja Rinke, Dr.
    - Contact:
      
      Erich Kort
    - Principal Investigator:
      
      Anja Rinke, Dr.
    - Sub-Investigator:
      
      Malte Zumblick, Dr.
    - Sub-Investigator:
      
      Sonja Gehring, Dr.
  - München, Germany
    - Recruiting
    - Klinik München-Bogenhausen
    - Contact:
      
      Martin Fuchs, Dr.
    - Contact:
      
      Bettina Huß
    - Principal Investigator:
      
      Martin Fuchs, Dr.
    - Sub-Investigator:
      
      Irene Klingenberg, Dr.
    - Sub-Investigator:
      
      Jael Nisenbaum, Dr.
    - Sub-Investigator:
      
      Fabian Hartmann, Dr.
  - Münster, Germany
    - Recruiting
    - Münster, Gemeinschaftspraxis für Hämatologie und Onkologie
    - Contact:
      
      Rüdiger Liersch, Dr.
    - Contact:
      
      Martina Ester
    - Principal Investigator:
      
      Rüdiger Liersch, Dr.
    - Sub-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.
  - Osnabrück, Germany, 49074
    - Recruiting
    - Niels-Stensen-Kliniken Osnabrück
    - Contact:
      
      Kerstin Schütte, Dr.
    - Contact:
      
      Birgit Unterberg
    - Principal Investigator:
      
      Kerstin Schütte, Dr.
    - Sub-Investigator:
      
      Kristina Middelberg-Bisping, Dr.
  - Ostfildern, Germany
    - Recruiting
    - Medius Klinik Osterfildern-Ruit
    - Contact:
      
      Bodo Klump, Prof. Dr.
    - Contact:
      
      Chistine Neumann
    - Principal Investigator:
      
      Bodo Klump, Prof. Dr.
    - Sub-Investigator:
      
      Alberta-May Daraban-Brixner, Dr.
    - Sub-Investigator:
      
      Nikolai Schuelper, Dr.
    - Sub-Investigator:
      
      Karin Waibel, Dr.
  - Regensburg, Germany
    - Recruiting
    - Krankenhaus Barmherzige Brüder
    - Sub-Investigator:
      
      Anke Schlenska-Lange, Dr.
    - Sub-Investigator:
      
      Jan Braess, Prof. Dr.
    - Contact:
      
      Nicolas Moosmann, Dr.
    - Contact:
      
      Christiane Reinert
    - Principal Investigator:
      
      Nicolas Moosmann, Dr.
    - Sub-Investigator:
      
      Nadia Maguire, Dr.
    - Sub-Investigator:
      
      V. Berberich, 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.
  - Rheine, Germany
    - Recruiting
    - Klinikum Rheine, Mathias-Spital Rheine
    - Contact:
      
      Sebastian Broeckling, Dr.
    - Contact:
      
      Kerstin Vehring
    - Principal Investigator:
      
      Sebastian Broeckling, Dr.
    - Sub-Investigator:
      
      Stefan Zicholl, Dr.
    - Sub-Investigator:
      
      Antonia Hansmeier, Dr.
    - Sub-Investigator:
      
      Guido Bisping, Dr.
  - Rosenheim, Germany, 83022
    - Recruiting
    - RoMed Klinikum Rosenheim
    - Contact:
      
      Gerhard Puchtler, Dr.
    - Contact:
      
      Senada Herrmann
    - Principal Investigator:
      
      Gerhard Puchtler, Dr.
    - Sub-Investigator:
      
      Ulrike Kolar-Michaelis, Dr.
  - Rostock, Germany, 18059
    - Recruiting
    - Klinikum Südstadt Rostock
    - Contact:
      
      Beate Krammer-Steiner, Dr.
    - Contact:
      
      Dèsirèe Pürschel
    - Principal Investigator:
      
      Beate Krammer-Steiner, Dr.
    - Sub-Investigator:
      
      Kerstin Peters, Dr.
    - Sub-Investigator:
      
      Sora Schipper, Dr.
    - Sub-Investigator:
      
      Henrike Broer
  - Saarbrücken, Germany
    - Recruiting
    - CaritasKlinikum Saarbrücken
    - Contact:
      
      Manfred Lutz, Prof. Dr.
    - Contact:
      
      Ulrike Schilling
    - Principal Investigator:
      
      Manfred Lutz, Prof. Dr.
    - Sub-Investigator:
      
      Michael Clemens, Prof. Dr.
    - Sub-Investigator:
      
      Anca A Cura, Dr.
    - Sub-Investigator:
      
      Jérôme Schwingel
  - Singen, Germany
    - Recruiting
    - Onkologie Bodensee
    - Contact:
      
      Thomas Fietz, Dr.
    - Contact:
      
      Karin Kingerter
    - Principal Investigator:
      
      Thomas Fietz, Dr.
    - Sub-Investigator:
      
      Christian Hertkorn, Dr.
    - Sub-Investigator:
      
      Niels Steinebrunner, Dr.
  - Wiesbaden, Germany, 65199
    - Recruiting
    - Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
    - Contact:
      
      Wolfgang Blau, Dr.
    - Contact:
      
      Sibylle Kerth-Krick
    - Principal Investigator:
      
      Wolfgang Blau, Dr.
    - Sub-Investigator:
      
      Natalia Heinz, Dr.
    - Sub-Investigator:
      
      Moritz Lesse, Dr.
  - Witten, Germany
    - Recruiting
    - Marien Hospital Witten
    - Sub-Investigator:
      
      Metin Senkal, Prof. Dr.
    - Contact:
      
      Matthias Zeth, Dr.
    - Contact:
      
      Katja Fritz
    - Principal Investigator:
      
      Matthias Zeth, Dr.
  - Wolfsburg, Germany
    - Recruiting
    - Klinikum Wolfsburg
    - Contact:
      
      Nils Homann, Prof. Dr.
    - Contact:
      
      Jeannette Wertmann
    - Principal Investigator:
      
      Nils Homann, Prof. Dr.
    - Sub-Investigator:
      
      Steffen Neumann, Dr.
    - Sub-Investigator:
      
      Janine Markgraf
    - Sub-Investigator:
      
      Alexander Behrens, Dr.
    - Sub-Investigator:
      
      Ulrike Weber
  - Wolfsburg, Germany
    - Recruiting
    - Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH
    - Contact:
      
      Thomas Gabrysiak, Dr.
    - Contact:
      
      Carina Kupke
    - Principal Investigator:
      
      Thomas Gabrysiak, Dr.
    - Sub-Investigator:
      
      Joachim Haessner, Dr.
    - Sub-Investigator:
      
      Katrin Heine, Dr.
    - Sub-Investigator:
      
      Jens Kersten
- Hessen
  - Frankfurt, Hessen, Germany, 60488
    - Recruiting
    - KHNW Frankfurt
    - Contact:
      
      Ulli Bankstahl
    - Principal Investigator:
      
      Thorsten Götze, Prof.
    - Sub-Investigator:
      
      Timursah Habibzade, Dr.
    - Contact:
      
      Thorsten Götze, Prof.
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Recruiting
    - Hannover Medical School
    - Contact:
      
      Bianca Lavae-Mokhtari
    - Principal Investigator:
      
      Arndt Vogel, Prof. Dr.
    - Sub-Investigator:
      
      Anna Saborowski, Dr.
    - Contact:
      
      Arndt Vogel, Prof. Dr.
- Schleswig-Holstein
  - Neumünster, Schleswig-Holstein, Germany, 24534
    - Recruiting
    - Friedrich-Ebert-Krankenhaus Neumünster
    - Contact:
      
      Siegfried Haas, Dr.
    - Sub-Investigator:
      
      Kristin Bajorat
    - Sub-Investigator:
      
      Paul Zimmermann, Dr.
    - Sub-Investigator:
      
      Karsten Hamann, Dr.
    - Contact:
      
      Stefan Mahlmann, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not able to understand all implications of study participation
No written informed consent
age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hepatocellular Cancer molecular profiling - hepatocellular cancer (HCC)	Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
Other: Cholangiocarcinoma molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)	Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
Other: Gallbladder Cancer molecular profiling - gallbladder carcinoma (GBCA)	Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
Other: Pancreatic Cancer molecular profiling - pancreatic cancer (PanCa)	Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
Other: Oesophageal Cancer + Stomach Cancer molecular profiling - esophagogastric cancer (EC/GC)	Diagnostic test: FoundationOne®CDx and FoundationOne®Liquid FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer Time Frame: 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.	up to 4 weeks after biospecimen provision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA Time Frame: up to 4 weeks after biospecimen provision	Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA	up to 4 weeks after biospecimen provision
Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group Time Frame: up to 4 weeks after biospecimen provision	Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group	up to 4 weeks after biospecimen provision
Number of patients receiving therapies in accordance to their genomic profiles Time Frame: up to 4 weeks after biospecimen provision	Number of patients receiving therapies in accordance to their genomic profiles	up to 4 weeks after biospecimen provision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators

Roche Pharma AG

Investigators

Study Director: Salah-Eddin Al-Batran, Prof., Institut für Klinische Krebsforschung IKF GmbH
Principal Investigator: Arndt Vogel, Prof., Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

The PLATON Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

PLATON pilot-study
AIO-HEP/STO-0219/ass (Other Identifier: AIO Arbeitsgemeinschaft Internistische Onkologie)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Depending on particpant informed concent individual-participant data (IPD) will only be shared in research-cooperations according the terms of PLATON's Use and Access Regulation. Scientific projects have to be approved by PLATON'S Scientific Steering Committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Stomach Cancer

Clinical Trials on FoundationOne®CDx and FoundationOne®Liquid

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