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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04099134
- Acronym / sponsor ID
- PaCaReg / PaCaReg
- Conditions
- Pancreas Adenocarcinoma, Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 23 Sep 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.
PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult newly diagnosed patients with a PDAC could be included in the registry trial.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- papillary cancer
- neuroendocrine pancreatic tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General assessment of applied therapy modalities in pancreatic cancer
Time frame: 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
3 secondary outcomes
General epidemiologic assessment
Time frame: 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)
Evaluation of predictive and prognostic markers
Time frame: First diagnose to death or end of surveillance (5 years after curative resection)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Thomas Seufferlein, MD principal investigator
Ulm University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma and Pancreas Cancer, run by University of Ulm at 1 site 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Seufferlein, MD (+49 731 50044501, thomas.seufferlein@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General assessment of applied therapy modalities in pancreatic cancer (time frame: First diagnose to death or end of surveillance (5 years after curative resection)). 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 25 Sep 2019.