Pancreatic cancer: validation of circulating predictive biomarkers
- Conditions
- pancreatic cancerpancreatic ductal adenocarcinoma1001567410017991
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
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).
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To validate the predictive value of circulating TP53 tumor mutations before<br /><br>chemotherapy in combination with a homozygote TP53 Pro72arg germline variant<br /><br>AND the predictive value of circulating microRNA 17-3p, 18a-5p, 194-5p, 24-3p,<br /><br>and 27a-3p expression before and after one cycle of chemotherapy for the<br /><br>prediction of progressive disease during FOLFIRINOX treatment in PDAC patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To collect blood samples of PDAC patients during chemotherapy treatment and<br />create a pancreatic biobank to investigate future predictive or prognostic<br />biomarkers. In addition, we will expand our biomarker research field with<br />fragmentomics for which we work together with the Amsterdam University Medical<br />Centre (Amsterdam UMC).<br />Finally, we will investigate the correlation between circulating biomarkers and<br />tissue IHC for molecular subtypes in pancreatic cancer.</p>