Primary Objective(s): In this study we try to unravel the behavior of stem cells in relation to their (stromal) niche, genetic mutations, altered RNA expression and expression of tumor markers in serum for better prognostication of pancreatic…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The expression of stem cell markers in cell cultures and xenograft models,
serum protein markers, and DNA/RNA profiles, will be correlated to
clinicopathological characteristics like survival and TNM classification.
Secondary outcome
Amount of viable tumor cells in biopsies taken at the OR/Pathology (quality
comparison).
Optimal procedures for processing of the tissues (we follow standard operating
procedures in the laboratories).
Background summary
Pancreatic adenocarcinoma is a malignancy with a poor prognosis. At this moment
resection is the only curative option, and even this only yields a 5 year
survival of less than 10 percent.
Furthermore, due to the nature of the tumor and the intense stromal reaction
around the tumor cells, pancreatic adenocarcinoma is relatively insensitive to
current chemotherapeutics. More insight into both the interaction of tumor
(stem)cells with their niche through altered signalling and selfrenewal
pathways, as well as the genetic mutations that underlie these entities can
provide a rationale for novel therapies. Correlating these tumor biology
parameters to clinicopathological outcome can identify patient subgroups with a
different prognosis and aid in the selection of patients who are eligible for
curative surgical therapy. At this moment we are not routinely collecting
material for these studies. By establishing a pancreas bio bank we want to
create a valuable source of tumor material stored and processed following high
quality standardized procedures following current guidelines.
Study objective
Primary Objective(s): In this study we try to unravel the behavior of stem
cells in relation to their (stromal) niche, genetic mutations, altered RNA
expression and expression of tumor markers in serum for better prognostication
of pancreatic carcinoma. For this we will include patients with a suspicion of
a pancreatic carcinoma undergoing explorative laparotomy with curative intent,
or patients who undergo biopsies for palliative treatment and assess tumor
biology in relation to clinicopathological parameters.
Secondary Objective: To create the optimal logistic procedures to provide a
standardized collection of all patient tissue biopsies and blood samples needed
for our research in both resectable and (a priori or during exploration)
irresectable patients, and to increase the biological integrity of the
pancreatic tissue by providing a dedicated logistic network between the
departments of Surgery, Pathology, Medical Oncology and the Center for
Experimental Molecular Medicine in the Academic Medical Center.
Study design
Creating the pancreas bio bank is a prospective process. Observational
laboratory studies (with DNA/RNA isolation, microarrays, cell culturing and
xenografting) will be performed with primary tumor specimens, metastases and
blood samples stored and processed in the bio bank.
Study burden and risks
For the patient there are no substantial burdens or risks associated with
participation in the study, since routine diagnostic and therapeutic procedures
are followed. The study will probably benefit future patients through an
increase in understanding of pancreatic tumorbiology.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Suspicion of potentially resectable and irresectable pancreatic malignancy on preoperative imaging
Exclusion criteria
Not able to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL36420.018.11 |