The PLATON Network

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (Other)

Overall Status

Recruiting

CT.gov ID

NCT05489250

Collaborator

(none)

1,000

Enrollment

Locations

139.1

Anticipated Duration (Months)

32.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer Cholangiocarcinoma Gallbladder Cancer Pancreatic Cancer Oesophageal Cancer Stomach Cancer

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)

Actual Study Start Date :

Oct 28, 2020

Anticipated Primary Completion Date :

May 31, 2032

Anticipated Study Completion Date :

May 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
HCC (Hepatocellular cancer) Hepatocellular cancer patients with NGS based molecular tumor profiling
CCA/GBCA (Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer) Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer patients with NGS based molecular tumor profiling
PanCa (Pancreatic cancer) Pancreatic cancer patients with NGS based molecular tumor profiling
EC/GC (Oesophagogastric cancer) Oesophagogastric cancer patients with NGS based molecular tumor profiling

Outcome Measures

Primary Outcome Measures

Frequency of targetable mutations in gastrointestinal cancer patients [annual interim-analysis (1 year)]
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
Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients [annual interim-analysis (1 year)]
Number of received therapies in or out accordance to genomic profiles

Secondary Outcome Measures

Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients [annual interim-analysis (1 year)]
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.
QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients [annual interim-analysis (1 year)]
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
QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients [annual interim-analysis (1 year)]
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.
QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients [annual interim-analysis (1 year)]
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".
QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients [annual interim-analysis (1 year)]
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.
QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients [annual interim-analysis (1 year)]
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.
QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients [annual interim-analysis (1 year)]
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.

Other Outcome Measures

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 [through study completion, an average of 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KHNW Frankfurt	Frankfurt	Hessen	Germany	60488
2	Friedrich-Ebert-Krankenhaus Neumünster	Neumünster	Schleswig-Holstein	Germany	24534
3	HELIOS Klinikum Bad Saarow	Bad Saarow		Germany
4	Evangelisches Waldkrankenhaus Spandau	Berlin		Germany
5	MVZ Oskar-Helene-Heim Berlin	Berlin		Germany
6	Augusta-Kranken-Anstalt Bochum	Bochum		Germany
7	Bochum Uni	Bochum		Germany
8	Klinikum Chemnitz	Chemnitz		Germany
9	GEFOS - Gesellschaft für onkologische Studien Dortmund	Dortmund		Germany
10	Onkozentrum Dresden	Dresden		Germany
11	Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie	Essen		Germany	45136
12	MVZ Onkologische Kooperation Harz	Goslar		Germany
13	Universitätsklinikum Halle (Saale)	Halle		Germany
14	Hamburg Onkologische Schwerpunktpraxis Eppendorf	Hamburg		Germany
15	St. Anna Hospital Herne	Herne		Germany
16	Ortenau Klinikum Lahr-Ettenheim	Lahr		Germany
17	ÜBAG - MVZ Dr. Vehling-Kaiser GmbH	Landshut		Germany
18	Langen, Gemeinschaftspraxis für Hämatologie und Onkologie	Langen		Germany
19	Studienzentrum UnterEms	Leer		Germany
20	Klinikum Lippe	Lemgo		Germany
21	Klinikum Ludwigsburg	Ludwigsburg		Germany
22	Klinik München-Bogenhausen	München		Germany
23	Münster, Gemeinschaftspraxis für Hämatologie und Onkologie	Münster		Germany
24	Medius Klinik Osterfildern-Ruit	Ostfildern		Germany
25	Krankenhaus Barmherzige Brüder	Regensburg		Germany
26	Klinikum Rheine, Mathias-Spital Rheine	Rheine		Germany
27	CaritasKlinikum Saarbrücken	Saarbrücken		Germany
28	Onkologie Bodensee	Singen		Germany
29	Marien Hospital Witten	Witten		Germany
30	Klinikum Wolfsburg	Wolfsburg		Germany
31	Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH	Wolfsburg		Germany

Sponsors and Collaborators

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Investigators

Study Director: Salah-Eddin Al-Batran, Prof. Dr., Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
Principal Investigator: Arndt Vogel, Prof. Dr., Hannover Medical School (MHH)