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2020-10-28
2024-08-30
2024-12-31
400
NCT04484636
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
INTERVENTIONAL
PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-10 | N/A | 2025-03-17 |
2020-07-21 | N/A | 2025-03-20 |
2020-07-23 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Hepatocellular Cancer molecular profiling - hepatocellular cancer (HCC) | DIAGNOSTIC_TEST: FoundationOne®CDx and FoundationOne®Liquid
|
| OTHER: Cholangiocarcinoma molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA) | DIAGNOSTIC_TEST: FoundationOne®CDx and FoundationOne®Liquid
|
| OTHER: Gallbladder Cancer molecular profiling - gallbladder carcinoma (GBCA) | DIAGNOSTIC_TEST: FoundationOne®CDx and FoundationOne®Liquid
|
| OTHER: Pancreatic Cancer molecular profiling - pancreatic cancer (PanCa) | DIAGNOSTIC_TEST: FoundationOne®CDx and FoundationOne®Liquid
|
| OTHER: Oesophageal Cancer + Stomach Cancer molecular profiling - esophagogastric cancer (EC/GC) | DIAGNOSTIC_TEST: FoundationOne®CDx and FoundationOne®Liquid
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
