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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484636
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : December 31, 2022
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (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 (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

Information from the National Library of Medicine

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


Contacts
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Contact: Arndt Vogel, Prof. Dr. +4969-7601-4420 vogela@me.com
Contact: Bianca Zäpf +4969-7601-4636 zaepf.bianca@ikf-khnw.de

Locations
Show Show 30 study locations
Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Roche Pharma AG
Investigators
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Principal Investigator: Salah-Eddin Al-Batran, Prof. Institut für Klinische Krebsforschung IKF GmbH
Principal Investigator: Arndt Vogel, Prof. Hannover Medical School
Additional Information:
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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: June 1, 2022
Last Verified: May 2022
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest:
Gastric cancer
Individualized cancer therapy
Targetable mutations
Foundation Medicine assays
Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Platform-Design
Biobanking
Additional relevant MeSH terms:
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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