Table 1 World Health Organization Trial Registration Data Set describing the PANCALYZE study
Data category | Information |
|---|---|
Primary registry and trial identifying number | German Clinical Trials Register (DRKS) http://drks-neu.uniklinik-freiburg.de/drks_web/ DRKS00006179 |
Date of registration in primary registry | 2014/05/20 |
Secondary identifying numbers | - |
Source(s) of monetary or material support | Department of General, Visceral and Cancer Surgery, University of Cologne, Germany Clinic for General, Visceral and Vascular Surgery, University Clinic Magdeburg, Germany Celgene GmbH, Joseph-Wild-Straße 20, 81,829 München |
Primary sponsor | Department of General, Visceral and Cancer Surgery, University of Cologne, Germany Kerpener Str. 62, 50,937 Köln |
Secondary sponsor(s) | - |
Contact for public queries | Dr. Felix Popp Department of General, Visceral and Cancer Surgery, University of Cologne, Germany Kerpener Str. 62, 50,937 Köln pancalyze@uk-koeln.de |
Contact for scientific queries | Dr. Felix Popp Department of General, Visceral and Cancer Surgery, University of Cologne, Germany Kerpener Str. 62, 50,937 Köln pancalyze@uk-koeln.de |
Public title | Evaluation of molecular markers to predict the pattern of tumor recurrence and prognosis in pancreatric ductal adenocarcinoma |
Scientific title | A multicenter, prospective study investigating the tumor biomarkers CXCR4, SMAD4, SOX9 and IFIT3 in patients with resected pancreatic adenocarcinoma to predict the pattern of recurrence of the disease |
Countries of recruitment | Germany |
Health condition(s) or problem(s) studied | C25 - Malignant neoplasm of pancreas |
Intervention(s) | none |
Key inclusion and exclusion criteria | inclusion criteria: patients with primary PDAC undergoing surgical resection exclusion criteria: Patient is inoperable, No tumor samples can be taken, no ductal adenocarcinoma or intraductal papillary mucinous neoplasm (IPMN) in the final histology |
Study type | Non-interventional observation |
Date of first enrolment | May 2014 |
Target sample size | 450 |
Recruitment status | Recruiting |
Primary outcome(s) | Correlation of biomarker expression and clinical course |
Key secondary outcomes | none |
Version | 2014/05/20 Original Version 1.0 |