NCT04119362

PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 469 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Quality of live questionnaires	EORTC-Q30 questionnaire, additonal questionnaire on worries about quality of life impairments and on physical condition every 8 weeks. No additional visits will be carried out for questionnaires. Questionnaires will be handed out to patients during routine visits.
OTHER	Optional translational project	Collection of archival tumor material for future translational projects. No biopsy will be performed in the context of this registry. Only tumor samples obtained in the context of standard of care and after explicit informed context will be used.

Timeline

• Start date: 2019-10-24
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2019-10-08
• Last updated: 2024-03-07

Locations

24 sites across 1 country: Germany