NCT04484636: PLATON

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

Completed NA Last updated 20 March 2025

What this trial tests

NA trial testing FoundationOne®CDx and FoundationOne®Liquid in Hepatocellular Cancer in 400 participants. Completed in 31 December 2024.

Timeline

28 October 2020

Primary endpoint
30 August 2024

31 December 2024

Quick facts

Lead sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	400
Start date	28 October 2020
Primary completion	30 August 2024
Estimated completion	31 December 2024
Sites	46 locations across Germany

Drugs / interventions tested

• FoundationOne®CDx and FoundationOne®Liquid

Conditions studied

• Hepatocellular Cancer — all drugs for Hepatocellular Cancer →
• Cholangiocarcinoma — all drugs for Cholangiocarcinoma →
• Gallbladder Cancer — all drugs for Gallbladder Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Cancer or Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liquid biopsy in gastric cancer: predictive and prognostic biomarkers.
   Zhang Z, Wu H, Chong W, Shang L, et al · · 2022 · cited 84× · PMID 36302755 · DOI 10.1038/s41419-022-05350-2
2. Beyond blood: Advancing the frontiers of liquid biopsy in oncology and personalized medicine.
   Bao Y, Zhang D, Guo H, Ma W. · · 2024 · cited 62× · PMID 38308498 · DOI 10.1111/cas.16097
3. Liquid Biopsy in Pancreatic Cancer: Are We Ready to Apply It in the Clinical Practice?
   Heredia-Soto V, Rodríguez-Salas N, Feliu J. · · 2021 · cited 50× · PMID 33924143 · DOI 10.3390/cancers13081986
4. Current Status of Circulating Tumor DNA Liquid Biopsy in Pancreatic Cancer.
   Grunvald MW, Jacobson RA, Kuzel TM, Pappas SG, et al · · 2020 · cited 49× · PMID 33081107 · DOI 10.3390/ijms21207651
5. Tumor Mutational Burden for Predicting Prognosis and Therapy Outcome of Hepatocellular Carcinoma.
   Gabbia D, De Martin S. · · 2023 · cited 40× · PMID 36834851 · DOI 10.3390/ijms24043441
6. The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
   Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
7. Decoding the Dynamics of Circulating Tumor DNA in Liquid Biopsies.
   Turabi K, Klute K, Radhakrishnan P. · · 2024 · cited 14× · PMID 39001494 · DOI 10.3390/cancers16132432
8. Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
   David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924