RecruitingNCT04370574

Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology

Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2)

Sponsor

University Hospital, Montpellier

Enrollment

200 participants

Start Date

Jan 14, 2021

Study Type

OBSERVATIONAL

Conditions

Pancreatic Neoplasms

Summary

Pancreatic ductal adenocarcinoma (PDAC) remains among cancers with a very poor prognosis (1-year survival \<20%). Endoscopic ultrasound with fine needle aspiration (EUS/FNA) is the common examination for all patients with suspicious pancreatic mass. A method was recently developed : it preserves the sanitary sample, named EXPEL, which allows standard pathology examination and OMICS analyzes from the "rinse" liquid. After EUS/FNA in clinical practice, the content of the needle is rinsed in CytoLyt® preservative solution. After cytofiltration, this liquid is systematically discarded. Based on the EXPEL concept, we hypothesise that this all-patients inclusive approach ("Modified EXPEL" procedure) combined with the methodology to access proteomic and metabolomics information in these original samples will allow us to identify a series of clinically useful marker signatures that will ultimately be measurable, non-invasively, in the patient blood.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy

Exclusion Criteria2

Vulberable person according to L1121-6 of Public health reglementation in France
Pregnant women

Interventions

DIAGNOSTIC_TESTSoluble Biomarkers dosage

1. CytoLyt® fluid will be first processed for routine PDAC diagnosis. In essence, the samples are filtered, tissue fragments and cells are kept for analysis while flow-through is kept until the diagnosis is confirmed. Once this is completed, the samples will be transferred to the lab where the proteins found in the CytoLytR fluid will be precipitated and then solubilized. The protein extracts are stored at -80°C pending proteomic analysis. The remaining CytoLytR fluid supernatant is also stored at - 80°C to be used for metabolomics. 2. Blood sample will be collected from each patient that underwent diagnostic biopsy. Dry tube for serum analysis will be collected at the time of inclusion during the routine blood test. The serum samples are intended for the validation phase (WP4) and will be exclusively dedicated to this study.