Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

Neoplasm Clinical Trial

Official title:

Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936104
• Other study ID #: BT-PDAC-SP
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: July 1, 2012
• Start date: August 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Resected pancreatic ductal adenocarcinoma (PDAC)

• Informed consent

Exclusion Criteria:

• Age < 18years

• Pregnancy

• Pre-operative radiotherapy

• Pre-operative chemotherapy

• IPMT

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm
• Pancreas

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)			No