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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Pregnant women

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Soluble Biomarkers dosage

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma

Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma Correlation with positive diagnosis of pancreatic ductal adenocarcinoma and proteins quantity in Cytolyt® samples using ROC curves (sensibility/specificity: Area Under the Curve \> 0.85) and binary logistic regression method with controlling for the effects of the co-variates (such as age, disease cTNM stage, and treatment details).

Time frame
Baseline

Secondary outcomes

1

Disease-free survival

Disease-free survival (percentage of patients without recurrence) .Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis

Time frame
One year
2

Disease-free survival

Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis. Disease-free survival (DFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause)

Time frame
One year
3

Overall survival

Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis Overall survival at 1 year (percentage of patients alive)

Time frame
One year
4

Identification of prognostically significant biomarkers

Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival analysis. Kaplan Meier analysis, logrank test and Cox's proportional hazards regression model to identify biomarkers that are prognostically significant (Hazard ratio (HR) and its 95% confidence interval (CI)

Time frame
One year

Other outcomes

Sponsors and contacts

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