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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04484636
Other study ID # PLATON pilot-study
Secondary ID AIO-HEP/STO-0219
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2020
Est. completion date July 30, 2024

Study information

Verified date April 2024
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact Arndt Vogel, Prof. Dr.
Phone +4969-7601-4420
Email vogela@me.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 400
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Germany HELIOS Klinikum Bad Saarow Bad Saarow
Germany Klinikum Bayreuth Bayreuth
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Evangelisches Waldkrankenhaus Spandau Berlin
Germany MVZ Oskar-Helene-Heim Berlin Berlin
Germany Vivantes Klinikum Spandau 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 KHNW Frankfurt Frankfurt Hessen
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 Hannover Medical School Hannover Niedersachsen
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 Friedrich-Ebert-Krankenhaus Neumünster Neumünster Schleswig-Holstein
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

Sponsors (2)

Lead Sponsor Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer 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 Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA up to 4 weeks after biospecimen provision
Secondary Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group up to 4 weeks after biospecimen provision
Secondary Number of patients receiving therapies in accordance to their genomic profiles Number of patients receiving therapies in accordance to their genomic profiles up to 4 weeks after biospecimen provision
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