To develop a model system and infrastructure to individualize the treatment of patients with advanced pancreatic adenocarcinoma. Additionally, we aim to identify predictors of therapy (non)response.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of organoids from biopsies of metastases or primary tumour
tissue of pancreatic cancer. The response of the organoids will be assessed for
correlation with clinical response.
Secondary outcome
The expression of bio markers in organoid, organotypic and xenograft models
will be investigated. DNA/RNA profiles will be correlated to clinical and
pathological characteristics such as therapy response, survival and TNM
classification.
Background summary
Pancreatic adenocarcinoma is a malignancy with a poor prognosis. Resection is
the only curative option and still 5-year survival rate is less than 10
percent. But most patients present with advanced disease and are provided with
palliative care. The nature of the tumour and the intense stromal reaction
around the tumour cells leave pancreatic adenocarcinoma relatively insensitive
to chemotherapeutics. Current models, such as cell lines or patient derived
xenografts, cannot provide predictive information in a clinically relevant
timeframe. Organoids and organotypic culture systems have emerged as promising
new culturing techniques that maintain some of the complexity of the tumour. As
most patients are ineligible for tumour resection, this project will focus on
metastases and will generate organoids from that tissue. Using a combination of
organoids and organotypic systems, treatment (non)response can be predicted,
which may provide a personalized treatment setting for patients with metastatic
pancreatic adenocarcinoma.
Study objective
To develop a model system and infrastructure to individualize the treatment of
patients with advanced pancreatic adenocarcinoma. Additionally, we aim to
identify predictors of therapy (non)response.
Study design
Observational laboratory studies (with DNA/RNA isolation, RNA sequencing, cell
culturing, organoid culturing and xenografting) will be performed with tumour
specimens. Response to drug (combinations) will be tested. Additionally, these
organoids will be stored for future research in a living organoid biobank.
Intervention
NA
Study burden and risks
Participating in this study requires a biopsy from the patient. The material
will be obtained from the biopsy required for diagnosis or the patient is asked
for consent for an additional tumour biopsy not required for diagnosis. The
study could benefit patients not directly, but their organoids provide valuable
information to start personalized therapy for patients with advanced pancreatic
cancer. In further studies organoids can be used to assess efficacy of
first-line treatment and when necessary may provide an advice for second-line
treatment options. Additionally, future patients may benefit, if biomarkers are
found to predict therapy (non)response.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients older than 18 years
- Diagnosed with locally advanced pancreatic cancer or metastatic pancreatic
cancer
- Able to understand the information given
- WHO 0-2
Exclusion criteria
- Unfit for biopsies & blood analyses in palliative chemotherapy studies
- Not able to give informed consent (language, intellectual capacities, etc.)
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL62539.018.17 |