Pancreatic AdenocarcinomaPARAGONNCT04119362
PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
An observational study of Pancreatic Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 24 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Quality of live questionnaires and Optional translational project
- How many people
- 469 participants
- Where
- 24 sitesGermany
- Study dates
- 24 Oct 2019to 30 Jun 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic adenocarcinoma
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Germany24 sites
HELIOS Klinikum Bad Saarow
Bad Saarow, 15526
MVZ am Oskar-Helene-Heim
Berlin
Klinikum Coburg
Coburg
Onkozentrum Dresden/Freiberg
Dresden
Gemeinschaftspraxis Hämatologie und Onkologie
Erfurt
Institute for Clinical Cancer Research Krankenhaus Nordwest
Frankfurt, 60488
Klinikum Frankfurt Höchst
Frankfurt
Universitätsklinikum Halle
Halle
Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin
Hamburg
St. Bernward Krankenhaus
Hildesheim
Klinikum Kassel Klinik für Hämatologie und Onkologie
Kassel
Klinikum Konstanz
Konstanz
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut
Landshut
Magdeburg, Klinikum Magdeburg gGmbH
Magdeburg
Mayen, Institut für Versorgungsforschung
Mayen
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster
Hämatologisch-Onkologische Schwerpunktpraxis
Naunhof
Friedrich-Ebert-Krankenhaus
Neumünster
medius KLINIK OSTFILDERN RUIT
Ostfildern
BAG Innere Medizin - Hämatologie - Onkologie
Regensburg, 93053
Elblandklinikum Riesa
Riesa, 01589
RoMed Klinikum Onkologische Tagesklinik
Rosenheim
Onkologische Schwerpunktpraxis
Speyer
Marienhospital
Stuttgart
About this study
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.
Read the 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
- Being tested
- Quality of live questionnaires, Optional translational project
- Keywords
- pancreas, quality of life, PRO, Pancreatic Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of live questionnairesOther
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.
Optional translational projectOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality of live questionnaires; Other: Optional translational project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Other patient reported outcome (PRO)
Physical performance status patient questionnaire according to ECOG criteria
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Progression- free survival (PFS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Measured: through study completion, an average of 1 year
Disease-free survival (DFS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Measured: through study completion, an average of 1 year
Overall survival (OS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start24 Oct 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 469 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof., Study director, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestThorsten Goetze, Prof., Principal investigator, Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische ForschungRalf Hofheinz, Prof., Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119362
- Sponsor's protocol ID
- PARAGON
- Other IDs
- AIO-LQ-0214
- Acronym
- PARAGON
- Status last verified
- Mar 2024
- First submitted
- 25 Sep 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04119362
- Acronym / sponsor ID
- PARAGON / PARAGON
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- pancreas, quality of life, PRO, Pancreatic Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic adenocarcinoma | – | Other: Quality of live questionnaires, Other: Optional translational projectPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic adenocarcinoma
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of live questionnairesEORTC-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 | Patients with pancreatic adenocarcinoma |
| Optional translational projectCollection 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. | Other | Patients with pancreatic adenocarcinoma |
Primary outcome
The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma
Time frame: through study completion, an average of 1 year
EORTC-QLQC30 according to EORTC scoring manual
Other patient reported outcome (PRO)
Time frame: through study completion, an average of 1 year
Physical performance status patient questionnaire according to ECOG criteria
3 secondary outcomes
Progression- free survival (PFS)
Time frame: through study completion, an average of 1 year
Disease-free survival (DFS)
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah-Eddin Al-Batran, Prof. study director
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Thorsten Goetze, Prof. principal investigator
Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
Ralf Hofheinz, Prof. principal investigator
Universitätsmedizin Mannheim
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 24 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.