The PLATON Network

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05489250

The PLATON Network

Details and patient eligibility

About

The PLATON Network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. Hereby, PLATON's study-design focuses on the patient's tumor molecular profiling. Within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at PLATON's study sites.

Full description

The PLATON Network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. The study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects.

Within PLATON results of genetic tests of different research projects like the PLATON pilot-study (NCT04484636) as well as Next-generation deep sequencing (NGS) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (TMB) and microsatellite instability (MSI).

The PLATON Network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. Therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. The feasibility of this approach will be tested in the PLATON Network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available
• Standard first line therapy is planned, or patient is currently receiving first-line therapy
• Available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study
• 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

1,000 participants in 4 patient groups

HCC (Hepatocellular cancer)

Description:

Hepatocellular cancer patients with NGS based molecular tumor profiling

CCA/GBCA (Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer)

Description:

Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer patients with NGS based molecular tumor profiling

PanCa (Pancreatic cancer)

Description:

Pancreatic cancer patients with NGS based molecular tumor profiling

EC/GC (Oesophagogastric cancer)

Description:

Oesophagogastric cancer patients with NGS based molecular tumor profiling