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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00936104
Other study ID # BT-PDAC-SP
Secondary ID
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


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
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