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

This study has been completed.
Sponsor:
Collaborators:
FWO Fonds voor Wetenschappelijk Onderzoek (FWO), Vlaanderen, Belgium
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00495924
First received: July 2, 2007
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495924

Locations
Belgium
Department of Abdominal Surgery, Catholic University Leuven
Leuven, Vlaams-Brabant, Belgium, B-3060
Sponsors and Collaborators
Katholieke Universiteit Leuven
FWO Fonds voor Wetenschappelijk Onderzoek (FWO), Vlaanderen, Belgium
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

No publications provided by Katholieke Universiteit Leuven

Additional 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
Study First Received: July 2, 2007
Last Updated: July 7, 2009
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

ClinicalTrials.gov processed this record on May 22, 2013