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

Pancreatic Cancer Clinical Trial

— PLATON  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms
• Hepatocellular Cancer
• Liver Neoplasms
• Oesophageal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Cancer
• Stomach Neoplasms

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

External Links

•   The PLATON Network