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

This study has been completed.

First Received: July 2, 2007 Last Updated: July 7, 2009 History of Changes

Sponsor:	Katholieke Universiteit Leuven
Collaborators:	FWO Fonds voor Wetenschappelijk Onderzoek (FWO), Vlaanderen, Belgium IWT Innovatie door Wetenschap en Technologie in Vlaanderen, Belgium
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00495924

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:	Cohort, Prospective
Official Title:	Prognostic Relevance of Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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, Vlaams-Brabant
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

IWT Innovatie door Wetenschap en Technologie in Vlaanderen, Belgium

Investigators

Study Director:	Baki Topal, MD, PhD	Catholic University Leuven, Belgium
Principal Investigator:	Gregory Sergeant, MD	Catholic University Leuven

More Information

Additional Information:

Official site of the Department of Abdominal Surgery, Catholic University Leuven This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Katholieke Universiteit Leuven ( Topal Baki, MD, PhD )
Study ID Numbers:	3M070038, G.0635.07
Study First Received:	July 2, 2007
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00495924 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Carcinoma
Neoplasms
Neoplastic Processes
Digestive System Diseases

Pathologic Processes
Neoplasms by Site
Neoplasm Metastasis
Pancreatic Diseases
Adenocarcinoma
Neoplasm Circulating Cells
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009