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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status: Completed

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

Treatments: Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04484636

AIO-HEP/STO-0219/ass (Other Identifier)

PLATON pilot-study

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 5 patient groups

Hepatocellular Cancer

Other group

Description:

molecular profiling - hepatocellular cancer (HCC)

Treatment:

Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

Cholangiocarcinoma

Other group

Description:

molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)

Treatment:

Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

Gallbladder Cancer

Other group

Description:

molecular profiling - gallbladder carcinoma (GBCA)

Treatment:

Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

Pancreatic Cancer

Other group

Description:

molecular profiling - pancreatic cancer (PanCa)

Treatment:

Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid

Oesophageal Cancer + Stomach Cancer

Other group

Description:

molecular profiling - esophagogastric cancer (EC/GC)

Treatment:

Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid