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

NCT04119362 | Completed

• 2 other identifiers: PARAGONAIO-LQ-0214
• Study Type: observational
• Target: 469
• Locations: 1 country
• Sites: 24

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

pancreas; quality of life; PRO; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma

  EORTC-QLQC30 according to EORTC scoring manual

  through study completion, an average of 1 year

• Other patient reported outcome (PRO)

  Physical performance status patient questionnaire according to ECOG criteria

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Progression- free survival (PFS)

  through study completion, an average of 1 year

• Disease-free survival (DFS)

  through study completion, an average of 1 year

• Overall survival (OS)

  through study completion, an average of 1 year

Study Arms (1)

Patients with pancreatic adenocarcinoma

Patients with metastatic pancreatic cancer receiving will be asked to fill in an EORTC QLQ-C30 questionnaire and additional questionnaires on worries about quality of life impairments and physical constitiution every 8 weeks, over the entire course of treatment, starting with neo-/adjuvant or 1st line therapy follow. There is no restriction on type of therapy. No further intervention.

Other: Quality of live questionnaires; Other: Optional translational project

Interventions

Quality of live questionnaires OTHER

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.

Patients with pancreatic adenocarcinoma

Optional translational project OTHER

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.

Patients with pancreatic adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic adenocarcinoma

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Celgene: collaborator

Study Sites (24)

HELIOS Klinikum Bad Saarow

Bad Saarow, 15526, Germany

Location

MVZ am Oskar-Helene-Heim

Berlin, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

Onkozentrum Dresden/Freiberg

Dresden, Germany

Location

Gemeinschaftspraxis Hämatologie und Onkologie

Erfurt, Germany

Location

Institute for Clinical Cancer Research Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

Klinikum Frankfurt Höchst

Frankfurt, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin

Hamburg, Germany

Location

St. Bernward Krankenhaus

Hildesheim, Germany

Location

Klinikum Kassel Klinik für Hämatologie und Onkologie

Kassel, Germany

Location

Klinikum Konstanz

Konstanz, Germany

Location

ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut

Landshut, Germany

Location

Magdeburg, Klinikum Magdeburg gGmbH

Magdeburg, Germany

Location

Mayen, Institut für Versorgungsforschung

Mayen, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, Germany

Location

Hämatologisch-Onkologische Schwerpunktpraxis

Naunhof, Germany

Location

Friedrich-Ebert-Krankenhaus

Neumünster, Germany

Location

medius KLINIK OSTFILDERN RUIT

Ostfildern, Germany

Location

BAG Innere Medizin - Hämatologie - Onkologie

Regensburg, 93053, Germany

Location

Elblandklinikum Riesa

Riesa, 01589, Germany

Location

RoMed Klinikum Onkologische Tagesklinik

Rosenheim, Germany

Location

Onkologische Schwerpunktpraxis

Speyer, Germany

Location

Marienhospital

Stuttgart, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin Fixed and Paraffin Embedded Tumor Tissue (FFPE)

Study Officials

• Salah-Eddin Al-Batran, Prof.

  Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

  STUDY DIRECTOR

• Thorsten Goetze, Prof.

  Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung

  PRINCIPAL INVESTIGATOR

• Ralf Hofheinz, Prof.

  Universitätsmedizin Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 8, 2019
• Study Start: October 24, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (24)