Clinical trial NCT04484636: PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Keywords: Gastric cancer
Individualized cancer therapy
Targetable mutations
Foundation Medicine assays
Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Platform-Design
Biobanking
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2020-07-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Experimental Study
Primary purpose: OTHER

Brief 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.

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

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

Primary outcomes:
measure: Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer
timeFrame: up to 4 weeks after biospecimen provision
Secondary outcomes:
measure: Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA
timeFrame: up to 4 weeks after biospecimen provision
measure: Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group
timeFrame: up to 4 weeks after biospecimen provision
measure: Number of patients receiving therapies in accordance to their genomic profiles
timeFrame: up to 4 weeks after biospecimen provision
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: KHNW Frankfurt
state: Hessen
city: Hannover
country: Germany
facility: Hannover Medical School
state: Niedersachsen
city: Speyer
country: Germany
facility: Onkologische Schwerpunktpraxis Speyer
state: Rheinland-Pfalz
city: Ried
country: Germany
facility: Elblandklinikum Riesa
state: Sachsen
city: Neumünster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Neumünster
state: Schleswig-Holstein
city: Borna
country: Germany
facility: Sana Kliniken Leipziger Land
state: Thüringen
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Berlin
country: Germany
facility: MVZ Oskar-Helene-Heim Berlin
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum
city: Bochum
country: Germany
facility: Bochum Uni
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Dortmund
country: Germany
facility: GEFOS - Gesellschaft für onkologische Studien Dortmund
city: Dresden
country: Germany
facility: Onkozentrum Dresden
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Hamburg Onkologisch-Hämatologische Schwerpunktpraxis
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm
city: Herne
country: Germany
facility: St. Anna Hospital Herne
city: Lahr
country: Germany
facility: Ortenau Klinikum Lahr-Ettenheim
city: Landshut
country: Germany
facility: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
city: Langen
country: Germany
facility: Langen, Gemeinschaftspraxis für Hämatologie und Onkologie
city: Leer
country: Germany
facility: Studienzentrum UnterEms
city: Lemgo
country: Germany
facility: Klinikum Lippe
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
city: München
country: Germany
facility: Klinik München-Bogenhausen
city: Münster
country: Germany
facility: Münster, Gemeinschaftspraxis für Hämatologie und Onkologie
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Osnabrück
city: Ostfildern
country: Germany
facility: Medius Klinik Osterfildern-Ruit
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Rheine
country: Germany
facility: Klinikum Rheine, Mathias-Spital Rheine
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken
city: Singen
country: Germany
facility: Onkologie Bodensee
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
city: Witten
country: Germany
facility: Marien Hospital Witten
city: Wolfsburg
country: Germany
facility: Klinikum Wolfsburg
city: Wolfsburg
country: Germany
facility: Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH
Study officials:
affiliation: Institut für Klinische Krebsforschung IKF GmbH
name: Salah-Eddin Al-Batran, Prof.
role: STUDY_DIRECTOR
affiliation: Hannover Medical School
name: Arndt Vogel, Prof.
role: PRINCIPAL_INVESTIGATOR
References: