Pancreas AdenocarcinomaPaCaRegNCT04099134
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma
An observational study of Pancreas Adenocarcinoma and Pancreas Cancer, run by University of Ulm at 1 site in Germany.
Trial summary
PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma, Pancreas Cancer
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2018to Oct 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
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: All adult newly diagnosed patients with a PDAC could be included in the registry trial.
Who may be able to join
- 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
Who cannot join
- papillary cancer
- neuroendocrine pancreatic tumors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Ulm
Ulm
Thomas Seufferlein, MD, 0049-731-500-44501, thomas.seufferlein@uniklinik-ulm.de
About this study
Official title: 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
- Conditions
- Pancreas Adenocarcinoma, Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
General assessment of applied therapy modalities in pancreatic cancer
Measured: First diagnose to death or end of surveillance (5 years after curative resection)
Quality of life in pancreatic cancer patients
EORTC QLQ c30 and PAN 26
Measured: First diagnose to death or end of surveillance (5 years after curative resection)
Secondary outcomes (3)
General epidemiologic assessment
Epidemiologic questionaire
Measured: First diagnose to death or end of surveillance (5 years after curative resection)
Assessment of tumor surveillance in pancreatic cancer patients
Measured: First diagnose to death or end of surveillance (5 years after curative resection)
Evaluation of predictive and prognostic markers
Measured: First diagnose to death or end of surveillance (5 years after curative resection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start10 Oct 2018
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Thomas Seufferlein, MD, Principal investigator, Ulm University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099134
- Sponsor's protocol ID
- PaCaReg
- Acronym
- PaCaReg
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No