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Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00495924
First Posted: July 3, 2007
Last Update Posted: July 8, 2009
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.
Collaborators:
Research Foundation Flanders
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Katholieke Universiteit Leuven
  Purpose
The purpose of this study is to determine whether early recurrence after curative resection of ductal pancreatic adenocarcinoma can be explained by either dissemination of cancer cells during intraoperative tumour manipulation, post-operative systemic immune suppression, alteration of biological properties of circulating cancer cells or a combination of these.

Condition Intervention
Pancreatic Neoplasms Adenocarcinoma Neoplasm Circulating Cells Tumor Markers, Biological Monitoring, Immunologic Procedure: Pancreatic resection (PD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Relevance of Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

Further study details as provided by Katholieke Universiteit Leuven:

Biospecimen Retention:   Samples With DNA
Tissue, serum, blood

Estimated Enrollment: 100
Study Start Date: October 2006
Study Completion Date: October 2008
Groups/Cohorts Assigned Interventions
PD
Patients undergoing pancreaticoduodenectomy for pancreatic or peri-ampullary tumours.
Procedure: Pancreatic resection (PD)
PD is a standard therapeutic surgical procedure. No additional interventions are performed.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing pancreaticoduodenectomy for pancreatic or peri-ampullary tumours.
Criteria

Inclusion Criteria:

  • Suspected ductal pancreatic adenocarcinoma (pathological confirmation required after resection of tumour);
  • Informed consent.

Exclusion Criteria:

  • Any malignant tumour within 5 years prior to pancreatic resection.
  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): NCT00495924


Locations
Belgium
Department of Abdominal Surgery, Catholic University Leuven
Leuven, Vlaams-Brabant, Belgium, B-3060
Sponsors and Collaborators
Katholieke Universiteit Leuven
Research Foundation Flanders
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Study Director: Baki Topal, MD, PhD Catholic University Leuven, Belgium
Principal Investigator: Gregory Sergeant, MD Catholic University Leuven
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Topal Baki, MD, PhD, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00495924     History of Changes
Other Study ID Numbers: 3M070038
G.0635.07
First Submitted: July 2, 2007
First Posted: July 3, 2007
Last Update Posted: July 8, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Pancreatic Neoplasms
Neoplastic Cells, Circulating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes