PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) (PLATON)
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ClinicalTrials.gov Identifier: NCT04484636 |
Recruitment Status :
Recruiting
First Posted : July 23, 2020
Last Update Posted : April 23, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Cancer Cholangiocarcinoma Gallbladder Cancer Pancreatic Cancer Oesophageal Cancer Stomach Cancer | Diagnostic Test: FoundationOne®CDx and FoundationOne®Liquid | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Experimental Study |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) A Multicenter, Prospective, Cohort Study To Assess The Genomic Profiles And Associated Therapy Decision In Gastrointestinal Cancer |
Actual Study Start Date : | October 28, 2020 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | July 30, 2024 |
Arm | Intervention/treatment |
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Hepatocellular Cancer
molecular profiling - hepatocellular cancer (HCC)
|
Diagnostic Test: FoundationOne®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. |
Cholangiocarcinoma
molecular profiling - intra- and extrahepatic cholangiocellular carcinoma (CCA)
|
Diagnostic Test: FoundationOne®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. |
Gallbladder Cancer
molecular profiling - gallbladder carcinoma (GBCA)
|
Diagnostic Test: FoundationOne®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. |
Pancreatic Cancer
molecular profiling - pancreatic cancer (PanCa)
|
Diagnostic Test: FoundationOne®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. |
Oesophageal Cancer + Stomach Cancer
molecular profiling - esophagogastric cancer (EC/GC)
|
Diagnostic Test: FoundationOne®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. |
- Distribution of mutations in patients with HCC, intra- and extrahepatic CCA, GBCA, PDAC and gastric cancer [ Time Frame: 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.
- Heterogeneity of targetable alterations in paraffin embedded specimen vs. cfDNA [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 4 weeks after biospecimen provision ]Number of patients receiving therapies in accordance to their genomic profiles
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484636
Contact: Arndt Vogel, Prof. Dr. | +4969-7601-4420 | vogela@me.com | |
Contact: Bianca Zäpf | +4969-7601-4636 | zaepf.bianca@ikf-khnw.de |
Study Director: | Salah-Eddin Al-Batran, Prof. | Institut für Klinische Krebsforschung IKF GmbH | |
Principal Investigator: | Arndt Vogel, Prof. | Hannover Medical School |
Responsible Party: | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
ClinicalTrials.gov Identifier: | NCT04484636 |
Other Study ID Numbers: |
PLATON pilot-study AIO-HEP/STO-0219/ass ( Other Identifier: AIO Arbeitsgemeinschaft Internistische Onkologie ) |
First Posted: | July 23, 2020 Key Record Dates |
Last Update Posted: | April 23, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Depending on particpant informed concent individual-participant data (IPD) will only be shared in research-cooperations according the terms of PLATON's Use and Access Regulation. Scientific projects have to be approved by PLATON'S Scientific Steering Committee. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastric cancer Individualized cancer therapy Targetable mutations Foundation Medicine assays Hepatocellular Cancer Cholangiocarcinoma |
Gallbladder Cancer Pancreatic Cancer Oesophageal Cancer Stomach Cancer Platform-Design Biobanking |
Pancreatic Neoplasms Cholangiocarcinoma Gallbladder Neoplasms Stomach Neoplasms Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Gastrointestinal Neoplasms Gastrointestinal Diseases Stomach Diseases Liver Diseases |