Cholangiocarcinoma, Gallbladder Cancer, Hepatocellular Cancer, Oesophageal Cancer, Pancreatic Cancer, Stomach Cancer
Conditions
Keywords
Gastric cancer, Individualized cancer therapy, Targetable mutations, Foundation Medicine assays, Hepatocellular Cancer, Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, Oesophageal Cancer, Stomach Cancer, Platform-Design, Biobanking
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.
Detailed 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
Interventions
DIAGNOSTIC_TESTFoundationOne®CDx and FoundationOne®Liquid
FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
Sponsors
Roche Pharma AG
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Experimental Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer | up to 4 weeks after biospecimen provision | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA | up to 4 weeks after biospecimen provision | Number of differences (heterogeneity) in targetable alterations in paraffin specimen vs. cfDNA |
| Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group | up to 4 weeks after biospecimen provision | Relative frequency of targetable mutations (incl. TMB and MSI status) per disease group |
| Number of patients receiving therapies in accordance to their genomic profiles | up to 4 weeks after biospecimen provision | Number of patients receiving therapies in accordance to their genomic profiles |
Countries
Germany
Outcome results
None listed