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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach

1 country

46 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

First Submitted

Initial submission to the registry

July 10, 2020

Completed

13 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed

3 months until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

March 20, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

July 10, 2020

Last Update Submit

March 17, 2025

Conditions

Hepatocellular Cancer Cholangiocarcinoma Gallbladder Cancer Pancreatic Cancer Oesophageal Cancer Stomach Cancer

Keywords

Gastric cancerIndividualized cancer therapyTargetable mutationsFoundation Medicine assaysHepatocellular CancerCholangiocarcinomaGallbladder CancerPancreatic CancerOesophageal CancerStomach CancerPlatform-DesignBiobanking

Outcome Measures

Primary Outcomes (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.
up to 4 weeks after biospecimen provision

Secondary Outcomes (3)

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