pancreatic cancer pancreatic ductal adenocarcinoma
Conditions
Interventions
Appendectomy during standard diagnostic laparoscopy or surgical resection in
all included patients. In addition, extra peripheral blood will be collected
for isolation of T cells and dendritic cells
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age between 35 and 80 years. • Histological or cytological confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma). • Planned diagnostic laparoscopy for LAPC or planned resection for (borderline) resectable PDAC. • Ability to undergo diagnostic laparoscopy and appendectomy. • Written informed consent.
Exclusion criteria
Exclusion criteria: • Previous appendectomy. • Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of pancreatic cancer. • Pregnancy. • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator. • Use of immune suppressive medication in the past 3 months ( including TNF-a antibody, azathioprine, mercaptopurine, methotrexaat, ciclosporin, adalimumab, infliximab, or vedolizumab therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify tumour specific oncolytic activity of VA-GALT derived T cells in patients with pancreatic cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare tumour specific antigens in plasma and tumor tissue of patients with PDAC. DNA sequencing will be used to identify mutant antigens, using the Accel-Amplicon 56G Oncology Panel v2 (Swift Biosciences), compatible with the Illumina HiSeq. If the tumor specific antigens in both plasma and tumor of the same patient are comparable we could use the plasma results in the future for peptide production. • To identify the distinct immune gene expression signature in VAs from patients with LAPC and (borderline) resectable PDAC compared to benign controls. To define the immune gene expression, we will use whole transcriptome RNA sequencing, or the nCounter PanCancer Immune Profiling Panel (nanoString) that includes 770 human genes. To validate abundance and location of the tumor specific genes on the protein level, identified genes will be validated by immunohistochemical staining of proteins in FFPE VA.. Proteins of interest are selected based on differentially expressed genes from the RNA analyses.. • To compare peripheral blood T-cell and B cell receptor repertoires versus lymphocytes of the VA in patients with PDAC. Using the ImmunoSEQ Assay (Adaptive Biotechnologies) T cells and B cell receptors will be sequenced using DNA from both PBMCs and from the of the VA lymphocytes. • To assess the VA microbiome we will collect fecal material of the resected appendix and perform metagenomics shotgun sequencing (Illumina). | — |
Countries
Netherlands
Outcome results
None listed