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Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer (GEMSTHER)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947102
First Posted: July 27, 2009
Last Update Posted: January 13, 2010
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. Read our disclaimer for details.
Collaborator:
University Medical Centre Ljubljana
Information provided by:
Blood Transfusion Centre of Slovenia
  Purpose
Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.

Condition Intervention
Pancreatic Tubular Adenocarcinoma Other: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study - Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Tubular Carcinoma

Resource links provided by NLM:


Further study details as provided by Blood Transfusion Centre of Slovenia:

Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pancreatic tubular adenocarcinoma
Patients with pancreatic tubular adenocarcinoma
Other: Observation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after resection of pancreatic tubular adenocarcinoma
Criteria

Inclusion Criteria:

  • ECOG performance status 0-2 at the time of inclusion
  • Following R0 or R1 pancreatic tubular adenocarcinoma resection

Exclusion Criteria:

  • Pregnancy
  • Serious comorbidity
  Contacts and Locations
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): NCT00947102


Contacts
Contact: Borut Stabuc, MD, PhD +386 1 522 22 10 borut.stabuc@kclj.si
Contact: Lojze Smid, MD lojze.smid.jr@mf.uni-lj.si

Locations
Slovenia
University Medical Centre Ljubljana; Department for Gastroenterology Recruiting
Ljubljana, Slovenia, 1000
Contact: Borut Stabuc, MD, PhD    +386 1 522 2210    borut.stabuc@kclj.si   
Contact: Lojze Smid, MD       lojze.smid.jr@mf.uni-lj.si   
Principal Investigator: Borut Stabuc, MD, PhD         
Sponsors and Collaborators
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
  More Information

Responsible Party: Primoz Rozman MD, PhD, Blood Transfusion Centre of Ljubljana
ClinicalTrials.gov Identifier: NCT00947102     History of Changes
Other Study ID Numbers: Gemcitabine1
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: January 13, 2010
Last Verified: July 2009

Keywords provided by Blood Transfusion Centre of Slovenia:
pancreatic tubular adenocarcinoma
gemcitabine
gene expression
immunological status
serological status
pancreatic tubular adenocarcinoma adjuvant setting

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs