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

NCT04484636

CompletedNA

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Conditions: Hepatocellular Cancer, Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, Oesophageal Cancer

Interventions: FoundationOne®CDx and FoundationOne®Liquid

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (46)
  • Frankfurt am Main, Hesse, Germany
  • Hanover, Lower Saxony, Germany
  • Speyer, Rhineland-Palatinate, Germany
  • Ried, Saxony, Germany
  • Neumünster, Schleswig-Holstein, Germany
  • Berlin, State of Berlin, Germany
  • Borna, Thuringia, Germany
  • Bad Saarow, Germany
  • Bayreuth, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Bochum, Germany
  • Chemnitz, Germany
  • Darmstadt, Germany
  • Dortmund, Germany
  • Dresden, Germany
  • Frankfurt, Germany
  • Fulda, Germany
  • Goslar, Germany
  • Halle, Germany
  • Hamburg, Germany
  • Hamm, Germany
  • Herne, Germany
  • Lahr, Germany
  • Landshut, Germany
  • Langen, Germany
  • Leer, Germany
  • Lemgo, Germany
  • + 16 more on CT.gov