Clinical trial NCT04119362: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma
Keywords: pancreas
quality of life
PRO
Pancreatic Adenocarcinoma
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2019-10-08
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic adenocarcinoma

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.

Eligibility criteria: Inclusion Criteria:

* Written informed consent and signed data protection form before any study specific intervention, including screening, will be done
* Age ≥ 18 years
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Systemic neoadjuvant, adjuvant, 1st line systemic therapy is planned or recently started (within last 14 days)

Exclusion Criteria:

* Patients who are unable to consent because they do not understand the nature, significance and implications of the study
* Patients who are unable to understand or fill out the QoL survey
* Patients in 2nd or further treatment lines that have not been documented for 1st line therapy within the study

Primary outcomes:
measure: The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma
timeFrame: through study completion, an average of 1 year
measure: Other patient reported outcome (PRO)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Progression- free survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: Disease-free survival (DFS)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Berlin
country: Germany
facility: MVZ am Oskar-Helene-Heim
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dresden
country: Germany
facility: Onkozentrum Dresden/Freiberg
city: Erfurt
country: Germany
facility: Gemeinschaftspraxis Hämatologie und Onkologie
city: Frankfurt
country: Germany
facility: Institute for Clinical Cancer Research Krankenhaus Nordwest
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus
city: Kassel
country: Germany
facility: Klinikum Kassel Klinik für Hämatologie und Onkologie
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Landshut
country: Germany
facility: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut
city: Magdeburg
country: Germany
facility: Magdeburg, Klinikum Magdeburg gGmbH
city: Mayen
country: Germany
facility: Mayen, Institut für Versorgungsforschung
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Naunhof
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis
city: Neumünster
country: Germany
facility: Friedrich-Ebert-Krankenhaus
city: Ostfildern
country: Germany
facility: medius KLINIK OSTFILDERN RUIT
city: Regensburg
country: Germany
facility: BAG Innere Medizin - Hämatologie - Onkologie
city: Riesa
country: Germany
facility: Elblandklinikum Riesa
city: Rosenheim
country: Germany
facility: RoMed Klinikum Onkologische Tagesklinik
city: Speyer
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Stuttgart
country: Germany
facility: Marienhospital
Study officials:
affiliation: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
name: Salah-Eddin Al-Batran, Prof.
role: STUDY_DIRECTOR
affiliation: Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
name: Thorsten Goetze, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin Mannheim
name: Ralf Hofheinz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: