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Brief Title: PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Official Title: PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Study ID: NCT04119362
Brief Summary: Due to the generally poor prognosis, with no chance of long-term survival, health related quality of life is a very important objective in the treatment of patients with pancreatic cancer. The non-interventional, prospective, multicentre PARAGON study is desinged to evaluate the health-related quality of life in patients with metastatic pancreatic cancer, by analyzing the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome.
Detailed Description: Pancreatic cancer is often diagnosed at an advanced stage, because most of the patients have no symptoms until the cancer metastasized. In the majority of study cases pancreatic cancer research focuses on therapy outcomes and prognosis. With poor prognosis and no chance of long-term survival, quality of life becomes a very significant purpose of pancreatic cancer care. The PARAGON study is designed to see a bigger picture by acquiring data on quality of life (QoL) and further outcome of patients with localized, locally advanced and metastatic pancreatic cancer and moreover to establish a sample collection for future biomarker analysis. The multicenter, prospective, permanent, register study PARAGON collects outcome data, patient reported outcomes (PRO), and tumor tissues of pancreatic cancer patients of both sexes and ages over 18 at approx. 80 German study sites. Patients diagnosed with pancreatic adenocarcinoma planned for (or recently started with) neoadjuvant, adjuvant or 1st line therapy can be included into the study. The data assessment includes data on demography, basic parameters, anamnesis, comorbidities, therapies, outcome and survival data as well as patient reported outcome in QoL at baseline and every 8 weeks. PARAGON's first objective is to determine the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome. Secondary outcome measurements are e.g. progression-free, disease-free and overall survival according to treatment line.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
MVZ am Oskar-Helene-Heim, Berlin, , Germany
Klinikum Coburg, Coburg, , Germany
Onkozentrum Dresden/Freiberg, Dresden, , Germany
Gemeinschaftspraxis Hämatologie und Onkologie, Erfurt, , Germany
Institute for Clinical Cancer Research Krankenhaus Nordwest, Frankfurt, , Germany
Klinikum Frankfurt Höchst, Frankfurt, , Germany
Universitätsklinikum Halle, Halle, , Germany
Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Hamburg, , Germany
St. Bernward Krankenhaus, Hildesheim, , Germany
Klinikum Kassel Klinik für Hämatologie und Onkologie, Kassel, , Germany
Klinikum Konstanz, Konstanz, , Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut, Landshut, , Germany
Magdeburg, Klinikum Magdeburg gGmbH, Magdeburg, , Germany
Mayen, Institut für Versorgungsforschung, Mayen, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Münster, , Germany
Hämatologisch-Onkologische Schwerpunktpraxis, Naunhof, , Germany
Friedrich-Ebert-Krankenhaus, Neumünster, , Germany
medius KLINIK OSTFILDERN RUIT, Ostfildern, , Germany
BAG Innere Medizin - Hämatologie - Onkologie, Regensburg, , Germany
Elblandklinikum Riesa, Riesa, , Germany
RoMed Klinikum Onkologische Tagesklinik, Rosenheim, , Germany
Onkologische Schwerpunktpraxis, Speyer, , Germany
Marienhospital, Stuttgart, , Germany
Name: Salah-Eddin Al-Batran, Prof.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
Role: STUDY_DIRECTOR
Name: Thorsten Goetze, Prof.
Affiliation: Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
Role: PRINCIPAL_INVESTIGATOR
Name: Ralf Hofheinz, Prof.
Affiliation: Universitätsmedizin Mannheim
Role: PRINCIPAL_INVESTIGATOR