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

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

Plain Language Summary

Simplified for easier understanding

This study is searching for blood-based biomarkers — proteins or other molecules that can be detected in blood or fluid samples — that could improve how pancreatic cancer is detected and diagnosed. Currently, pancreatic cancer is often found late, when it is harder to treat. Better biomarkers could lead to earlier detection. **You may be eligible if:** - You have a pancreatic mass (growth) that is suspected to be pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You are already scheduled for an endoscopic ultrasound with a fine needle biopsy to evaluate your pancreatic mass **You may NOT be eligible if:** - You are a protected or vulnerable person under French public health regulations - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Uh Montpellier

Montpellier, Montpellier, France

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NCT04370574


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