Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00936104
First received: July 7, 2009
Last updated: July 1, 2012
Last verified: July 2012
  Purpose

In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.


Condition
Neoplasm
Pancreas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC) [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Pancreatic cancer tissue specimen


Enrollment: 20
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
SP in PDAC
Side population cells isolated from resection specimens obtained from patients with pancreatic cancer

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

SP cells will be identified through incubation with vital dye Hoechst 33342 of cell suspensions that are obtained from fresh human pancreatic cancer resection specimens.

Criteria

Inclusion Criteria:

  • Resected pancreatic ductal adenocarcinoma (PDAC)
  • Informed consent

Exclusion Criteria:

  • Age < 18years
  • Pregnancy
  • Pre-operative radiotherapy
  • Pre-operative chemotherapy
  • IPMT
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00936104

Locations
Belgium
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

No publications provided by University Hospital, Gasthuisberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00936104     History of Changes
Other Study ID Numbers: BT-PDAC-SP
Study First Received: July 7, 2009
Last Updated: July 1, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
pancreas
cancer
stem cell

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014