We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936104
First Posted: July 9, 2009
Last Update Posted: July 3, 2012
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.
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
  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 Baki Topal, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00936104


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

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
First Submitted: July 7, 2009
First Posted: July 9, 2009
Last Update Posted: July 3, 2012
Last Verified: July 2012

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