pancreatic cancer pancreatic ductal adenocarcinoma
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Experimental group • Age >= 18 years. • Diagnosed with (borderline) resectable, locally advanced or metastatic PDAC. • Treatment with FOLFIRINOX chemotherapy, including neoadjuvant therapy. • Written informed consent (either for PANCAKE in case of locally advanced PDAC and metastasized PDAC or for the PREOPANC-2/PREOPANC-3 trial in case of (borderline) resectable PDAC). Control group • Age >= 18 years. • Diagnosed with (borderline) resectable, locally advanced or metastatic PDAC. • Treatment with gemcitabine, with or without nab-paclitaxel, chemotherapy, including neoadjuvant therapy. • Written informed consent (either for PANCAKE in case of locally advanced PDAC and metastasized PDAC or for the PREOPANC-2 trial in case of (borderline) resectable PDAC).
Exclusion criteria
Exclusion criteria: Experimental group • Combined treatment with other chemotherapeutics then FOLFIRINOX. • Previous treatment with FOLFIRINOX chemotherapy. • 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. Control group • Combined treatment with other chemotherapeutics then gemcitabine and nab-paclitaxel. • Previous treatment with FOLFIRINOX or gemcitabine-based chemotherapy. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the predictive value of circulating TP53 tumor mutations before chemotherapy in combination with a homozygote TP53 Pro72arg germline variant AND the predictive value of circulating microRNA 17-3p, 18a-5p, 194-5p, 24-3p, and 27a-3p expression before and after one cycle of chemotherapy for the prediction of progressive disease during FOLFIRINOX treatment in PDAC patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| To collect blood samples of PDAC patients during chemotherapy treatment and create a pancreatic biobank to investigate future predictive or prognostic biomarkers. In addition, we will expand our biomarker research field with fragmentomics for which we work together with the Amsterdam University Medical Centre (Amsterdam UMC). Finally, we will investigate the correlation between circulating biomarkers and tissue IHC for molecular subtypes in pancreatic cancer. | — |
Countries
Netherlands
Outcome results
None listed