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

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Oesophageal Cancer; Gallbladder Cancer; Cholangiocarcinoma; Hepatocellular Cancer; Stomach Cancer

• Registration Number: NCT04484636
• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Study Start: 2020-10-28
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer	up to 4 weeks after biospecimen provision	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.

Secondary Outcome Measures

Name	Time	Method
Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA	up to 4 weeks after biospecimen provision	Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA
Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group	up to 4 weeks after biospecimen provision	Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group
Number of patients receiving therapies in accordance to their genomic profiles	up to 4 weeks after biospecimen provision	Number of patients receiving therapies in accordance to their genomic profiles

Trial Locations

Locations (46)

Onkologische Schwerpunktpraxis Speyer; 🇩🇪 Speyer, Rheinland-Pfalz, Germany

Elblandklinikum Riesa; 🇩🇪 Ried, Sachsen, Germany

Sana Kliniken Leipziger Land; 🇩🇪 Borna, Thüringen, Germany

KHNW Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Hannover Medical School; 🇩🇪 Hannover, Niedersachsen, Germany

Friedrich-Ebert-Krankenhaus Neumünster; 🇩🇪 Neumünster, Schleswig-Holstein, Germany

HELIOS Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Vivantes Klinikum Spandau; 🇩🇪 Berlin, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

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