PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma (PaCaReg)

September 23, 2019 updated by: Thomas Seufferlein, University of Ulm

PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma

PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult newly diagnosed patients with a PDAC could be included in the registry trial.

Description

Inclusion Criteria:

  • Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)
  • Age =>18 years
  • written informed consent

Exclusion Criteria:

  • papillary cancer
  • neuroendocrine pancreatic tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General assessment of applied therapy modalities in pancreatic cancer
Time Frame: First diagnose to death or end of surveillance (5 years after curative resection)
First diagnose to death or end of surveillance (5 years after curative resection)
Quality of life in pancreatic cancer patients
Time Frame: First diagnose to death or end of surveillance (5 years after curative resection)
EORTC QLQ c30 and PAN 26
First diagnose to death or end of surveillance (5 years after curative resection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General epidemiologic assessment
Time Frame: First diagnose to death or end of surveillance (5 years after curative resection)
Epidemiologic questionaire
First diagnose to death or end of surveillance (5 years after curative resection)
Assessment of tumor surveillance in pancreatic cancer patients
Time Frame: First diagnose to death or end of surveillance (5 years after curative resection)
First diagnose to death or end of surveillance (5 years after curative resection)
Evaluation of predictive and prognostic markers
Time Frame: First diagnose to death or end of surveillance (5 years after curative resection)
First diagnose to death or end of surveillance (5 years after curative resection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Thomas Seufferlein, MD, Ulm University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2018

Primary Completion (ANTICIPATED)

October 1, 2028

Study Completion (ANTICIPATED)

October 1, 2029

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (ACTUAL)

September 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PaCaReg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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