Pancreatic Cancer Clinical Trial
— PLATONOfficial title:
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Roche Pharma AG |
Germany,
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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