NCT00936104

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 3, 2012

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

July 7, 2009

Last Update Submit

July 1, 2012

Conditions

Keywords

pancreascancerstem cell

Outcome Measures

Primary Outcomes (1)

  • Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)

Study Arms (1)

SP in PDAC

Side population cells isolated from resection specimens obtained from patients with pancreatic cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Resected pancreatic ductal adenocarcinoma (PDAC)
  • Informed consent

You may not qualify if:

  • Age \< 18years
  • Pregnancy
  • Pre-operative radiotherapy
  • Pre-operative chemotherapy
  • IPMT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • Van den Broeck A, Gremeaux L, Topal B, Vankelecom H. Human pancreatic adenocarcinoma contains a side population resistant to gemcitabine. BMC Cancer. 2012 Aug 15;12:354. doi: 10.1186/1471-2407-12-354.

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic cancer tissue specimen

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 3, 2012

Record last verified: 2012-07

Locations