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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05489250
Other study ID # The PLATON Network
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date May 31, 2032

Study information

Verified date December 2023
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact Salah-Eddin Al-Batran, Prof. Dr.
Phone +49 (0)69-7601-4420
Email platon@ikf-khnw.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date May 31, 2032
Est. primary completion date May 31, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany HELIOS Klinikum Bad Saarow Bad Saarow
Germany Evangelisches Waldkrankenhaus Spandau Berlin
Germany MVZ Oskar-Helene-Heim Berlin Berlin
Germany Augusta-Kranken-Anstalt Bochum Bochum
Germany Bochum Uni Bochum
Germany Klinikum Chemnitz Chemnitz
Germany GEFOS - Gesellschaft für onkologische Studien Dortmund Dortmund
Germany Onkozentrum Dresden Dresden
Germany Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie Essen
Germany KHNW Frankfurt Frankfurt Hessen
Germany MVZ Onkologische Kooperation Harz Goslar
Germany Universitätsklinikum Halle (Saale) Halle
Germany Hamburg Onkologische Schwerpunktpraxis Eppendorf Hamburg
Germany St. Anna Hospital Herne Herne
Germany Ortenau Klinikum Lahr-Ettenheim Lahr
Germany ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut
Germany Langen, Gemeinschaftspraxis für Hämatologie und Onkologie Langen
Germany Studienzentrum UnterEms Leer
Germany Klinikum Lippe Lemgo
Germany Klinikum Ludwigsburg Ludwigsburg
Germany Klinik München-Bogenhausen München
Germany Münster, Gemeinschaftspraxis für Hämatologie und Onkologie Münster
Germany Friedrich-Ebert-Krankenhaus Neumünster Neumünster Schleswig-Holstein
Germany Medius Klinik Osterfildern-Ruit Ostfildern
Germany Krankenhaus Barmherzige Brüder Regensburg
Germany Klinikum Rheine, Mathias-Spital Rheine Rheine
Germany CaritasKlinikum Saarbrücken Saarbrücken
Germany Onkologie Bodensee Singen
Germany Marien Hospital Witten Witten
Germany Klinikum Wolfsburg Wolfsburg
Germany Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH Wolfsburg

Sponsors (1)

Lead Sponsor Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility of the PLATON WebApp - an interactive platform that connects the participating physicians on cases, cancer types, mutations, protein expressions and therapies, possible trials and discussion options for medical professionals The feasibility will be analyzed with a usability questionnaire regarding user experience, design criteria etc. of the newly designed infrastructure and an additional count on possible matches of cancer patients with defined genetic tumor-profiles to possible targeted therapy strategies. through study completion, an average of 2 years
Primary Frequency of targetable mutations in gastrointestinal cancer patients Relative frequency of targetable mutations computed as the number of patients who harbor at least one mutation divided by the number of total patients in the analyzed patient population annual interim-analysis (1 year)
Primary Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients Number of received therapies in or out accordance to genomic profiles annual interim-analysis (1 year)
Secondary Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients Overall survival measurement over time grouped by diagnostic cohorts and adjusted by age and sex will be correlated to treatments, while genomic profiles had or had not impact on decision for treatment. annual interim-analysis (1 year)
Secondary QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients QoL measurements are done over time in the palliative setting. Gastrointestinal cancer patient cohorts will be grouped by diagnostics and adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment in gastrointestinal cancer patients.
EQ-5D data is used in summary statistics at each observational timepoint and to estimate the difference between health states like "Mobility", "Looking After Myself", "Doing Usual Activities", "Having Pain or Discomfort", "Feeling Worried, Sad or Unhappy" in diagnostic groups of different treatments over time. The EQ VAS (visual analogue scale) on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health) indicates patients´ overall health on the day of questionnaire completion and will be used as measure of central tendency and dispersion
annual interim-analysis (1 year)
Secondary QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients QoL measurements are done over time in the palliative setting. Gastrointestinal cancer patient cohorts will be grouped by diagnostics and adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment in gastrointestinal cancer patients.
EORTC QLQ-C30 data is used in summary statistics at each observational timepoint to analyze five function subscales (physical, role, emotional, cognitive and social), nine symptom subscales/items (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties) and a global health/ QoL subscale following the QLQ-C30 scoring manual.
annual interim-analysis (1 year)
Secondary QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients QoL measurements are done over time in the palliative setting. The CCA and GBCA patients cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.
QoL in CCA and GBCA patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-BIL21 and analyzed according validated manual, forming nine symptom subscales/items for "Eating", "Jaundice", "Tiredness", "Pain" and "Anxiety".
annual interim-analysis (1 year)
Secondary QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients QoL measurements are done over time in the palliative setting. The HCC patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.
QoL in HCC patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-HCC18 and analyzed according validated manual, forming symptom scales for "Fatigue", "Body Image", "Jaundice", "Nutrition", "Pain" and "Fever" as well as single items like "Abdominal swelling" and "Sex life" in summary statistics at each observational timepoint.
annual interim-analysis (1 year)
Secondary QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients QoL measurements are done over time in the palliative setting. The PDCA patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.
QoL in PDCA patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-PAN26 and analyzed according validated manual, forming eight scales to assess "Pancreatic pain", "Digestive symptoms", "Altered bowel habit", "Hepatic, body image", "Satisfaction with health care", and "Sex life" in summary statistics at each observational timepoint.
annual interim-analysis (1 year)
Secondary QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients QoL measurements are done over time in the palliative setting. The EC/GC patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.
QoL in EC/GC patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-STO22 and analyzed according validated manual, forming five multi-item scales to assess "dysphagia", "pain", "reflux", "eating" and "anxiety" as well as four single items like "dry mouth", "taste", "body image" and "hair loss" in summary statistics at each observational timepoint.
annual interim-analysis (1 year)
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