Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099134
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Seufferlein, University of Ulm

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

Condition or disease
Pancreas Adenocarcinoma Pancreas Cancer

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 2028
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. General assessment of applied therapy modalities in pancreatic cancer [ Time Frame: First diagnose to death or end of surveillance (5 years after curative resection) ]
  2. 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


Secondary Outcome Measures :
  1. General epidemiologic assessment [ Time Frame: First diagnose to death or end of surveillance (5 years after curative resection) ]
    Epidemiologic questionaire

  2. Assessment of tumor surveillance in pancreatic cancer patients [ Time Frame: First diagnose to death or end of surveillance (5 years after curative resection) ]
  3. Evaluation of predictive and prognostic markers [ Time Frame: First diagnose to death or end of surveillance (5 years after curative resection) ]

Biospecimen Retention:   Samples With DNA
  • Tumor tissue from biopsies or surgery
  • Blood samples at defined timepoints


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult newly diagnosed patients with a PDAC could be included in the registry trial.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099134


Contacts
Layout table for location contacts
Contact: Thomas Seufferlein, MD +49 731 50044501 thomas.seufferlein@uniklinik-ulm.de

Locations
Layout table for location information
Germany
Universitätsklinikum Ulm Recruiting
Ulm, Germany
Contact: Thomas Seufferlein, MD    0049-731-500-44501    thomas.seufferlein@uniklinik-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
Layout table for investigator information
Principal Investigator: Thomas Seufferlein, MD Ulm University Hospital
Layout table for additonal information
Responsible Party: Thomas Seufferlein, Head of department for internal medicine I, University of Ulm
ClinicalTrials.gov Identifier: NCT04099134    
Other Study ID Numbers: PaCaReg
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases