- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936104
Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)
July 1, 2012 updated by: Baki Topal, University Hospital, Gasthuisberg
Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospital Leuven
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Resected pancreatic ductal adenocarcinoma (PDAC)
- Informed consent
Exclusion Criteria:
- Age < 18years
- Pregnancy
- Pre-operative radiotherapy
- Pre-operative chemotherapy
- IPMT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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SP in PDAC
Side population cells isolated from resection specimens obtained from patients with pancreatic cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 8, 2009
First Posted (Estimate)
July 9, 2009
Study Record Updates
Last Update Posted (Estimate)
July 3, 2012
Last Update Submitted That Met QC Criteria
July 1, 2012
Last Verified
July 1, 2012
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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