a. Generate a tissuebank of fresh frozen tissue samples for biomarker research by establishing protocols and logistics for tissue collection, storage, annotation and retrieval. With additional goal the applicability in the standard clinical…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Generation of a tissuebank of fresh-frozen tumorsamples
Validation of the PamChip technology in terms of stability and logistics
Research on tumorspecific kinase profiles and their potential inhibitors
Research on predictive and prognostic biomarkers with the help of miRNA
expression profiles, phosphoproteomics and kinase profiles
Secondary outcome
not applicable
Background summary
Health research is focussing on the development of new drugs,improving their
efficacy and reducing side effects. In this effort personalized medicine is an
emerging field that promises significant changes by selecting the right patient
for the right drug. Biomarkers - molecules or molecular activities linked to
disease state - are the tools to facilitate this selection of patients and
drugs. The access to patient derived biospecimens like tissues and blood is
crucial to discover and validate these biomarkers. In addition such research
will support the development of new drugs. Thus far, biomarker research has
focussed on DNA, and tissue markers, which was based on using paraffin embedded
and formalin fixed tissues. However, much information is lost in such samples,
which would have been preserved if they were collected and stored freshly
(*fresh frozen*). In recent years, the use of DNA and RNA arrays is increasing.
Many new technologies like kinase activity profiling and
phosphoproteomics,require these fresh frozen samples. Tissuebanking activities
have been started in academic institutes while most samples can be collected in
larger community hospitals. Generating a tissuebank in a community hospital is
therefore very important. The availability of fresh frozen tumor samples will
be increasingly important in the near future for the tailoring of the treatment
of many cancer patients. Not solely for the treatment of the primary tumor, but
also for the treatment of possible metastases.
Biomarker research is lately also focussing on bloodsamples. Taking a
bloodsample voor biomarker research will be increasingly important.
Also The Jeroen Bosch Hospital is and stays owner of the tissues from the
tissuebank. PamGene BV can, for this study, only use the tissues offered by
the Jeroen Bosch Hospital for research and only for the time of the research
contract. Tissue and bloodsamples of patients, included in this study, could
also be used for further biomarker research in collaboration with VU medical
centre.
Study objective
a. Generate a tissuebank of fresh frozen tissue samples for biomarker research
by establishing protocols and logistics for tissue collection, storage,
annotation and retrieval. With additional goal the applicability in the
standard clinical practice
b. Validation of the use of PamChip based kinase activity profiling on fresh
frozen samples in term of robustness and logistics (qualitative analysis).
c. Generate a case in which samples from this tissuebank have been used in
biomarker research using kinase activity profiling, starting by (1) exploring
the heterogeneity of colorectal- and breast cancers, (2) possibilities for
kinase activity based subtyping, and (3) new options for drug therapy in breast
and colorectal cancer by testing ex-vivo and on-chip drug effects.
d. Further biomarker research, like phosphoproteomics and miRNA
expression profiles on the tumor and bloodsamples in collaboration with VU
medical centre
Study design
none interventional research at mentally competent subjects of 18 years or
older who are operated for a maligancy
Study burden and risks
Except for the extraction of a bloodsample, no extra burden or risk are
expected
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
malignant tumor starting with breast and colorectal cancer
Exclusion criteria
none
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 | NL33661.028.10 |