Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pancreatic Adenocarcinoma
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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, qualit...

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.

Tracking Information

NCT #
NCT04119362
Collaborators
Celgene
Investigators
Principal Investigator: Salah-Eddin Al-Batran, Prof. Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung Principal Investigator: Thorsten Goetze, MD Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung Principal Investigator: Ralf Hofheinz, Prof. Universitätsmedizin Mannheim