Pancreatic NeoplasmsPanEXPEL2NCT04370574
Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology
An observational study of Pancreatic Neoplasms, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Soluble Biomarkers dosage
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy.
Who may be able to join
- Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy
Who cannot join
- Vulberable person according to L1121-6 of Public health reglementation in France
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, Montpellier, 34280
About this study
Official title: Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2)
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.
Read the detailed description
Clinical and pathological data will be prospectively collected to obtain 2 subgroups: PDAC and non-PDAC according to the final biopsy diagnosis. A combined quantitative analysis of the proteins and their peptides contained in CytoLyt® will be performed. ROC curves, AUC, sensitivity, specificity, positive predictive value and negative predictive value associated to biomarkers will be calculated to isolate combinations of diagnostic biomarkers. Candidate biomarkers will be validated by immunohistochemistry and multiple reaction monitoring. Prognostic biomarkers will be evaluated by generating 1-year overall survival curves and Cox regression.
The present research, modeled on current practice, employs novel and holistic approach - PANEXPEL methodology - to establish a new repertoire of biomarkers for pancreatic cancer. We intent to provide a comprehensive proteomic and metabolomics biomarker signature that will be measurable in the patient blood using common clinical methods. The potential for translation "from benchside to bedside" is especially high due to the involvement of clinical teams. We expect to propose a combined, robust protein/metabolite biomarker signature that can be rapidly tested in the clinics.
Necessary biological resources: Biological resources will include Cytolyt® and Blood Samples, accompanied by a signed Free and Informed Consent for each included patient.
- CytoLyt® fluid will be first processed by Pathology Dept. of the CHU 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.
- Blood sample will be collected from each patient that underwent diagnostic biopsy. Dry tube for serum analysis 5 ml will be collected at the time of inclusion during the routine blood test (mandatory assessment pre-operative or pre-chemotherapy). The blood sample is centrifuged at 1500xg for 15 minutes while the resulting sera are aliquoted (500μl/aliquot; 4-5 aliquots per patient) and stored at -80°C. These samples will be stored at Biologic Resources Center (CRB Montpellier) that is labelled NF-S-96900 (AFNOR). The serum samples are intended for the validation phase (WP4) and will be exclusively dedicated to this study.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Soluble Biomarkers dosage
- Keywords
- Biopsy, Fine-Needle, diagnostic imaging, Endosonography
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Biomarkers dosageDiagnostic test
- 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.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (4)
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
Measured: One year
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)
Measured: One year
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)
Measured: One year
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)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start14 Jan 2021
- Primary completion14 Jan 2021
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370574
- Sponsor's protocol ID
- RECHMPL20_0191
- Acronym
- PanEXPEL2
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2)
- ClinicalTrials.gov ID
- NCT04370574
- Acronym / sponsor ID
- PanEXPEL2 / RECHMPL20_0191
- Conditions
- Pancreatic Neoplasms
- Keywords
- Biopsy, Fine-Needle, diagnostic imaging, Endosonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinical and pathological data will be prospectively collected to obtain 2 subgroups: PDAC and non-PDAC according to the final biopsy diagnosis. A combined quantitative analysis of the proteins and their peptides contained in CytoLyt® will be performed. ROC curves, AUC, sensitivity, specificity, positive predictive value and negative predictive value associated to biomarkers will be calculated to isolate combinations of diagnostic biomarkers. Candidate biomarkers will be validated by immunohistochemistry and multiple reaction monitoring. Prognostic biomarkers will be evaluated by generating 1-year overall survival curves and Cox regression.
The present research, modeled on current practice, employs novel and holistic approach - PANEXPEL methodology - to establish a new repertoire of biomarkers for pancreatic cancer. We intent to provide a comprehensive proteomic and metabolomics biomarker signature that will be measurable in the patient blood using common clinical methods. The potential for translation "from benchside to bedside" is especially high due to the involvement of clinical teams. We expect to propose a combined, robust protein/metabolite biomarker signature that can be rapidly tested in the clinics.
Necessary biological resources: Biological resources will include Cytolyt® and Blood Samples, accompanied by a signed Free and Informed Consent for each included patient.
- CytoLyt® fluid will be first processed by Pathology Dept. of the CHU 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.
- Blood sample will be collected from each patient that underwent diagnostic biopsy. Dry tube for serum analysis 5 ml will be collected at the time of inclusion during the routine blood test (mandatory assessment pre-operative or pre-chemotherapy). The blood sample is centrifuged at 1500xg for 15 minutes while the resulting sera are aliquoted (500μl/aliquot; 4-5 aliquots per patient) and stored at -80°C. These samples will be stored at Biologic Resources Center (CRB Montpellier) that is labelled NF-S-96900 (AFNOR). The serum samples are intended for the validation phase (WP4) and will be exclusively dedicated to this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy.
Key inclusion criteria (1 listed)
- Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy
Key exclusion criteria (2 listed)
- Vulberable person according to L1121-6 of Public health reglementation in France
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble Biomarkers dosage1. 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. | Diagnostic test | – |
Primary outcome
Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma
Time frame: Baseline
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).
4 secondary outcomes
Disease-free survival
Time frame: One year
Disease-free survival
Time frame: One year
Overall survival
Time frame: One year
Identification of prognostically significant biomarkers
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Régis SOUCHE, MD (+33467337069, fr-souche@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.