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Hepatocellular CancerPLATONNCT04484636

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

A study testing FoundationOne®CDx and FoundationOne®Liquid in people with Hepatocellular Cancer and Cholangiocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 46 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FoundationOne®CDx and FoundationOne®Liquid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
46 sitesGermany
Study dates
28 Oct 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Not able to understand all implications of study participation
  • No written informed consent
  • age < 18 years

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Germany46 sites

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

  • Klinikum Bayreuth

    Bayreuth, 95445

  • MVZ Oskar-Helene-Heim Berlin

    Berlin, State of Berlin

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Evangelisches Waldkrankenhaus Spandau

    Berlin

  • Augusta-Kranken-Anstalt Bochum

    Bochum

  • Bochum Uni

    Bochum

  • Sana Kliniken Leipziger Land

    Borna, Thuringia, D-04552

  • Klinikum Chemnitz

    Chemnitz

  • Klinikum Darmstadt

    Darmstadt

  • GEFOS - Gesellschaft für onkologische Studien Dortmund

    Dortmund

  • Onkozentrum Dresden

    Dresden

  • Klinikum Frankfurt Höchst

    Frankfurt, 65929

  • KHNW Frankfurt

    Frankfurt am Main, Hesse, 60488

  • Klinikum Fulda

    Fulda, 36043

  • MVZ Onkologische Kooperation Harz

    Goslar

  • Universitätsklinikum Halle (Saale)

    Halle

  • Hamburg Onkologisch-Hämatologische Schwerpunktpraxis

    Hamburg, 22457

  • Evangelisches Krankenhaus Hamm

    Hamm, 59063

  • Hannover Medical School

    Hanover, Lower Saxony, 30625

  • St. Anna Hospital Herne

    Herne

  • Ortenau Klinikum Lahr-Ettenheim

    Lahr

  • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH

    Landshut

  • Langen, Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen

  • Studienzentrum UnterEms

    Leer

  • Klinikum Lippe

    Lemgo

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Universitätsklinikum Giessen und Marburg GmbH

    Marburg, 35043

  • Klinik München-Bogenhausen

    München

  • Münster, Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster

  • Friedrich-Ebert-Krankenhaus Neumünster

    Neumünster, Schleswig-Holstein, 24534

  • Niels-Stensen-Kliniken Osnabrück

    Osnabrück, 49074

  • Medius Klinik Osterfildern-Ruit

    Ostfildern

  • Krankenhaus Barmherzige Brüder

    Regensburg

  • Klinikum Rheine, Mathias-Spital Rheine

    Rheine

  • Elblandklinikum Riesa

    Ried, Saxony, D-01589

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • CaritasKlinikum Saarbrücken

    Saarbrücken

  • Onkologie Bodensee

    Singen

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, Rhineland-Palatinate, D-67346

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

    Wiesbaden, 65199

  • Marien Hospital Witten

    Witten

  • Klinikum Wolfsburg

    Wolfsburg

  • Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH

    Wolfsburg

Other trials in Germany

About this 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

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.

Read the 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

Being tested
FoundationOne®CDx and FoundationOne®Liquid
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
Medical subject headings
Liver Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FoundationOne®CDx and FoundationOne®LiquidDiagnostic test

    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.

Study groups in NCT04484636
Study groupRoleWhat they receive
Hepatocellular CancerOthermolecular profiling - hepatocellular cancer (HCC)
Receives: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid
CholangiocarcinomaOthermolecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)
Receives: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid
Gallbladder CancerOthermolecular profiling - gallbladder carcinoma (GBCA)
Receives: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid
Pancreatic CancerOthermolecular profiling - pancreatic cancer (PanCa)
Receives: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid
Oesophageal Cancer + Stomach CancerOthermolecular profiling - esophagogastric cancer (EC/GC)
Receives: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 4 weeks after biospecimen provision

Secondary outcomes (3)

  1. Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA

    Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA

    Measured: up to 4 weeks after biospecimen provision

  2. 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

    Measured: up to 4 weeks after biospecimen provision

  3. Number of patients receiving therapies in accordance to their genomic profiles

    Number of patients receiving therapies in accordance to their genomic profiles

    Measured: up to 4 weeks after biospecimen provision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start28 Oct 2020
  3. Primary completion30 Aug 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Model description
Experimental Study
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484636
Sponsor's protocol ID
PLATON pilot-study
Other IDs
AIO-HEP/STO-0219/ass
Acronym
PLATON
Status last verified
Jan 2025
First submitted
10 Jul 2020
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Depending on particpant informed concent individual-participant data (IPD) will only be shared in research-cooperations according the terms of PLATON's Use and Access Regulation. Scientific projects have to be approved by PLATON'S Scientific Steering Committee.

Questions about this trial

What is this clinical trial studying?

A study testing FoundationOne®CDx and FoundationOne®Liquid in people with Hepatocellular Cancer and Cholangiocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 46 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer (time frame: up to 4 weeks after biospecimen provision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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