Pancreatic CancerNCT07875582
Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma
An observational study of Pancreatic Cancer and Chronic Pancreatitis, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The goal of this prospective multicenter observational study is to evaluate the diagnostic accuracy of blood-based protein biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC) in adults aged 18 years and older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- Blood-Based Protein Biomarker Assessment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 8 Oct 2026to Dec 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: The study population will consist of patients recruited from two tertiary referral centers in Romania: the Institute of Gastroenterology and Hepatology at Sf. Spiridon County Clinical Emergency Hospital in Iași and Fundeni Clinical Institute in Bucharest. Participants will be prospectively enrolled during routine clinical care in the gastroenterology departments of the participating institutions.
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC), chronic pancreatitis, intraductal papillary mucinous neoplasm (IPMN), or mucinous cystic neoplasm (MCN)
- Histopathological confirmation mandatory for PDAC and optional for benign pancreatic conditions
- Diagnosis of benign pancreatic conditions confirmed by imaging criteria and/or a minimum clinical follow-up of 12 months
- Written informed consent
Who cannot join
- Less than 3 months since resolution of the most recent episode of acute pancreatitis
- Other active malignancies
- Severe systemic inflammatory diseases
- Oncological treatment initiated before blood sample collection, including chemotherapy or surgical resection
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catalin V Sfarti, medical doctor, professor contact
Romania1 site, 1 recruiting
- Recruiting
Saint Spiridon Emergency County Hospital
Iași
Roxana Grigorovici, +40752082830, grigorovici.roxana@d.umfiasi.ro
About this study
Official title: Evaluation of the Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma: A Prospective Multicenter Observational Study to Differentiate Pancreatic Cancer From Chronic Pancreatitis and Mucinous Pancreatic Lesions
The goal of this prospective multicenter observational study is to evaluate the diagnostic accuracy of blood-based protein biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC) in adults aged 18 years and older. The study will investigate whether these biomarkers can help distinguish pancreatic cancer from chronic pancreatitis and mucinous pancreatic lesions, including intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms (MCNs).
The main questions it aims to answer are:
Read more
Can blood-based protein biomarkers accurately identify patients with PDAC and distinguish them from patients with chronic pancreatitis or mucinous pancreatic lesions?
Does combining protein biomarkers with CA 19-9 improve diagnostic accuracy compared with using individual biomarkers alone?
Are protein biomarker levels associated with tumor stage, tumor size, or the presence of metastases in patients with PDAC?
Researchers will compare blood levels of protein biomarkers across four groups of patients: those with PDAC, chronic pancreatitis, IPMNs, and MCNs. The biomarkers will include GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A.
Participants will:
Provide informed consent before enrollment.
Provide an additional blood sample for protein biomarker measurement, collected alongside routine blood tests and before any oncological or interventional treatment.
Have relevant clinical information, medical history, laboratory results, and imaging findings collected for analysis.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy frequently diagnosed at advanced stages, when curative treatment options are limited. Early diagnosis remains challenging, particularly when distinguishing PDAC from benign inflammatory conditions, such as chronic pancreatitis, or from mucinous pancreatic lesions with malignant potential. Although carbohydrate antigen 19-9 (CA 19-9) is widely used in clinical practice, its diagnostic performance is limited, especially in early-stage disease and in differentiating malignant from benign pancreatic conditions.
Emerging blood-based protein biomarkers involved in inflammation, tumor progression, cell adhesion, and tissue remodeling may improve the diagnostic evaluation of pancreatic diseases. The combined assessment of multiple biomarkers, particularly alongside CA 19-9, may provide greater diagnostic accuracy than individual markers.
This study is designed as a prospective, multicenter, observational cohort study conducted at two tertiary medical centers in Romania: Institute of Gastroenterology and Hepatology, Saint Spiridon County Clinical Emergency Hospital in Iasi and Fundeni Clinical Institute in Bucharest.
Patients will be enrolled into four diagnostic groups according to their underlying pancreatic condition: PDAC, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and mucinous cystic neoplasms (MCNs). For secondary analyses, these groups may be classified into malignant (PDAC), premalignant (IPMN and MCN), and benign inflammatory (chronic pancreatitis) categories.
At enrollment, demographic characteristics, relevant medical history, clinical findings, laboratory parameters, and imaging data will be collected. Disease-related information, including pancreatic lesion characteristics, diagnostic confirmation, and treatment history, will also be recorded.
Blood samples will be collected at both participating centers before the initiation of oncological or interventional treatment. Protein biomarker measurements will be performed centrally at the Immunology Laboratory of Sf. Spiridon County Clinical Emergency Hospital in Iași, using a validated Luminex-based multiplex assay in accordance with the manufacturer's instructions and standardized laboratory procedures.
The investigated protein biomarkers include growth differentiation factor-15 (GDF-15), intercellular adhesion molecule-1 (ICAM-1), osteopontin, C-X-C motif chemokine ligand 10 (CXCL10), hepatocyte growth factor (HGF), Nectin-4, periostin, and vascular endothelial growth factor A (VEGF-A). CA 19-9 and routine laboratory parameters will also be assessed.
Statistical analyses will include descriptive and comparative methods to examine differences in plasma biomarker concentrations across the diagnostic groups. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis and related measures of diagnostic accuracy. Multivariable logistic regression will be used to investigate the independent diagnostic contribution of individual biomarkers and their combined performance with CA 19-9.
The study is observational, and all diagnostic and therapeutic decisions will remain part of routine clinical care. No experimental treatments will be administered. Patient information will be coded and handled confidentially in accordance with applicable data protection regulations.
The findings may contribute to the development of more accurate blood-based diagnostic strategies for differentiating pancreatic cancer from benign and potentially premalignant pancreatic diseases.
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm
- Being tested
- Blood-Based Protein Biomarker Assessment
- Keywords
- Protein Biomarkers, Diagnostic Biomarkers, Early Detection, GDF-15, Pancreatic Ductal Adenocarcinoma, PDAC, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm (IPMN), Mucinous Cystic Neoplasm (MCN), CA 19-9
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-Based Protein Biomarker AssessmentDiagnostic test
Blood samples will be collected for the measurement of circulating protein biomarkers, including GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A, using a validated Luminex-based multiplex assay. CA 19-9 levels will also be assessed. Biomarker concentrations will be compared across the four diagnostic groups to evaluate their ability to differentiate pancreatic ductal adenocarcinoma from chronic pancreatitis and mucinous pancreatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) | Adult patients diagnosed with histologically confirmed pancreatic ductal adenocarcinoma (PDAC). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. Receives: Diagnostic Test: Blood-Based Protein Biomarker Assessment | |
| Chronic Pancreatitis | Adult patients diagnosed with chronic pancreatitis, including mass-forming chronic pancreatitis. Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. Receives: Diagnostic Test: Blood-Based Protein Biomarker Assessment | |
| Intraductal Papillary Mucinous Neoplasm (IPMN) | Adult patients diagnosed with intraductal papillary mucinous neoplasms (IPMNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. Receives: Diagnostic Test: Blood-Based Protein Biomarker Assessment | |
| Mucinous Cystic Neoplasm (MCN) | Adult patients diagnosed with mucinous cystic neoplasms (MCNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. Receives: Diagnostic Test: Blood-Based Protein Biomarker Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Blood-Based Protein Biomarkers for Pancreatic Ductal Adenocarcinoma
The diagnostic accuracy of circulating protein biomarkers (GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A) for identifying pancreatic ductal adenocarcinoma (PDAC) will be assessed using receiver operating characteristic (ROC) curve analysis. Diagnostic performance will be quantified by the area under the ROC curve (AUC), sensitivity, specificity, and predictive values.
Measured: At baseline (study enrollment, prior to oncological or interventional treatment)
Secondary outcomes (3)
Differences in Plasma Protein Biomarker Levels Across Pancreatic Disease Groups
Plasma concentrations of GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A will be compared among patients with pancreatic ductal adenocarcinoma, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and mucinous cystic neoplasms (MCNs). Differences in biomarker concentrations between the four diagnostic groups will be assessed using appropriate statistical tests.
Measured: At baseline (study enrollment)
Diagnostic Performance of Combined Protein Biomarkers and CA 19-9
The diagnostic performance of protein biomarkers combined with CA 19-9 will be compared with that of individual biomarkers. Receiver operating characteristic (ROC) curve analysis will be used to assess the area under the curve (AUC), sensitivity, specificity, and predictive values of combined biomarker models for detecting pancreatic ductal adenocarcinoma.
Measured: At baseline (study enrollment)
Diagnostic Discrimination Between Pancreatic Ductal Adenocarcinoma and Benign or Mucinous Pancreatic Conditions
The ability of circulating protein biomarkers to differentiate pancreatic ductal adenocarcinoma from chronic pancreatitis and from mucinous pancreatic lesions (IPMNs and MCNs) will be evaluated. Separate diagnostic comparisons will be performed for PDAC versus chronic pancreatitis and PDAC versus mucinous pancreatic lesions, using ROC curve analysis and diagnostic accuracy measures.
Measured: At baseline (study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start8 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Clinic Fundeni, Sf Spiridon County Clinical Emergency Hospital, Iasi, Romania
- Responsible party
- Principal investigator, Roxana Grigorovici, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Roxana Grigorovici, Principal investigator, "Grigore T. Popa" University of Medicine and Pharmacy Iasi, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875582
- Sponsor's protocol ID
- 826/7.10.2026
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations. The data will be used exclusively for the purposes of the current study, in accordance with the informed consent provided by participants and applicable data protection regulations.
Publications
1. Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021;326(9):851-862. 2. Boyd LNC, et al. Diagnostic accuracy and added value of blood-based protein biomarkers for pancreatic cancer: A meta-analysis of aggregate and individual participant data. eClinicalMedicine. 2023;55:101747. 3. Koopmann J, et al. Serum markers in patients with resectable pancreatic adenocarcinoma: macrophage inhibitory cytokine 1 versus CA19-9. Clin Cancer Res. 2006;12(2):442-446. 4. Kim Y, et al. Development and Multiple Validation of the Protein Multi-marker Panel for Diagnosis of Pancreatic Cancer. Clin Cancer Res. 2021;27(8):2236-2245. 5. Ohtsuka T, et al. International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas. Pancreatology. 2024;24(2):255-270.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma: A Prospective Multicenter Observational Study to Differentiate Pancreatic Cancer From Chronic Pancreatitis and Mucinous Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT07875582
- Acronym / sponsor ID
- 826/7.10.2026
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm
- Keywords
- Protein Biomarkers, Diagnostic Biomarkers, Early Detection, GDF-15, Pancreatic Ductal Adenocarcinoma, PDAC, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm (IPMN)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Institutul Clinic Fundeni, Sf Spiridon County Clinical Emergency Hospital, Iasi, Romania
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
The goal of this prospective multicenter observational study is to evaluate the diagnostic accuracy of blood-based protein biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC) in adults aged 18 years and older. The study will investigate whether these biomarkers can help distinguish pancreatic cancer from chronic pancreatitis and mucinous pancreatic lesions, including intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms (MCNs).
The main questions it aims to answer are:
Can blood-based protein biomarkers accurately identify patients with PDAC and distinguish them from patients with chronic pancreatitis or mucinous pancreatic lesions?
Does combining protein biomarkers with CA 19-9 improve diagnostic accuracy compared with using individual biomarkers alone?
Are protein biomarker levels associated with tumor stage, tumor size, or the presence of metastases in patients with PDAC?
Researchers will compare blood levels of protein biomarkers across four groups of patients: those with PDAC, chronic pancreatitis, IPMNs, and MCNs. The biomarkers will include GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A.
Participants will:
Provide informed consent before enrollment.
Provide an additional blood sample for protein biomarker measurement, collected alongside routine blood tests and before any oncological or interventional treatment.
Have relevant clinical information, medical history, laboratory results, and imaging findings collected for analysis.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy frequently diagnosed at advanced stages, when curative treatment options are limited. Early diagnosis remains challenging, particularly when distinguishing PDAC from benign inflammatory conditions, such as chronic pancreatitis, or from mucinous pancreatic lesions with malignant potential. Although carbohydrate antigen 19-9 (CA 19-9) is widely used in clinical practice, its diagnostic performance is limited, especially in early-stage disease and in differentiating malignant from benign pancreatic conditions.
Emerging blood-based protein biomarkers involved in inflammation, tumor progression, cell adhesion, and tissue remodeling may improve the diagnostic evaluation of pancreatic diseases. The combined assessment of multiple biomarkers, particularly alongside CA 19-9, may provide greater diagnostic accuracy than individual markers.
This study is designed as a prospective, multicenter, observational cohort study conducted at two tertiary medical centers in Romania: Institute of Gastroenterology and Hepatology, Saint Spiridon County Clinical Emergency Hospital in Iasi and Fundeni Clinical Institute in Bucharest.
Patients will be enrolled into four diagnostic groups according to their underlying pancreatic condition: PDAC, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and mucinous cystic neoplasms (MCNs). For secondary analyses, these groups may be classified into malignant (PDAC), premalignant (IPMN and MCN), and benign inflammatory (chronic pancreatitis) categories.
At enrollment, demographic characteristics, relevant medical history, clinical findings, laboratory parameters, and imaging data will be collected. Disease-related information, including pancreatic lesion characteristics, diagnostic confirmation, and treatment history, will also be recorded.
Blood samples will be collected at both participating centers before the initiation of oncological or interventional treatment. Protein biomarker measurements will be performed centrally at the Immunology Laboratory of Sf. Spiridon County Clinical Emergency Hospital in Iași, using a validated Luminex-based multiplex assay in accordance with the manufacturer's instructions and standardized laboratory procedures.
The investigated protein biomarkers include growth differentiation factor-15 (GDF-15), intercellular adhesion molecule-1 (ICAM-1), osteopontin, C-X-C motif chemokine ligand 10 (CXCL10), hepatocyte growth factor (HGF), Nectin-4, periostin, and vascular endothelial growth factor A (VEGF-A). CA 19-9 and routine laboratory parameters will also be assessed.
Statistical analyses will include descriptive and comparative methods to examine differences in plasma biomarker concentrations across the diagnostic groups. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis and related measures of diagnostic accuracy. Multivariable logistic regression will be used to investigate the independent diagnostic contribution of individual biomarkers and their combined performance with CA 19-9.
The study is observational, and all diagnostic and therapeutic decisions will remain part of routine clinical care. No experimental treatments will be administered. Patient information will be coded and handled confidentially in accordance with applicable data protection regulations.
The findings may contribute to the development of more accurate blood-based diagnostic strategies for differentiating pancreatic cancer from benign and potentially premalignant pancreatic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) | – | Diagnostic Test: Blood-Based Protein Biomarker AssessmentAdult patients diagnosed with histologically confirmed pancreatic ductal adenocarcinoma (PDAC). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. |
| Chronic Pancreatitis | – | Diagnostic Test: Blood-Based Protein Biomarker AssessmentAdult patients diagnosed with chronic pancreatitis, including mass-forming chronic pancreatitis. Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. |
| Intraductal Papillary Mucinous Neoplasm (IPMN) | – | Diagnostic Test: Blood-Based Protein Biomarker AssessmentAdult patients diagnosed with intraductal papillary mucinous neoplasms (IPMNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. |
| Mucinous Cystic Neoplasm (MCN) | – | Diagnostic Test: Blood-Based Protein Biomarker AssessmentAdult patients diagnosed with mucinous cystic neoplasms (MCNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients recruited from two tertiary referral centers in Romania: the Institute of Gastroenterology and Hepatology at Sf. Spiridon County Clinical Emergency Hospital in Iași and Fundeni Clinical Institute in Bucharest. Participants will be prospectively enrolled during routine clinical care in the gastroenterology departments of the participating institutions.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC), chronic pancreatitis, intraductal papillary mucinous neoplasm (IPMN), or mucinous cystic neoplasm (MCN)
- Histopathological confirmation mandatory for PDAC and optional for benign pancreatic conditions
- Diagnosis of benign pancreatic conditions confirmed by imaging criteria and/or a minimum clinical follow-up of 12 months
- Written informed consent
Key exclusion criteria (5 listed)
- Less than 3 months since resolution of the most recent episode of acute pancreatitis
- Other active malignancies
- Severe systemic inflammatory diseases
- Oncological treatment initiated before blood sample collection, including chemotherapy or surgical resection
- Refusal to participate
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 |
|---|---|---|
| Blood-Based Protein Biomarker AssessmentBlood samples will be collected for the measurement of circulating protein biomarkers, including GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A, using a validated Luminex-based multiplex assay. CA 19-9 levels will also be assessed. Biomarker concentrations will be compared across the four diagnostic groups to evaluate their ability to differentiate pancreatic ductal adenocarcinoma from chronic pancreatitis and mucinous pancreatic lesions. | Diagnostic test | Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm (IPMN), Mucinous Cystic Neoplasm (MCN), Pancreatic Ductal Adenocarcinoma (PDAC) |
Primary outcome
Diagnostic Accuracy of Blood-Based Protein Biomarkers for Pancreatic Ductal Adenocarcinoma
Time frame: At baseline (study enrollment, prior to oncological or interventional treatment)
The diagnostic accuracy of circulating protein biomarkers (GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A) for identifying pancreatic ductal adenocarcinoma (PDAC) will be assessed using receiver operating characteristic (ROC) curve analysis. Diagnostic performance will be quantified by the area under the ROC curve (AUC), sensitivity, specificity, and predictive values.
3 secondary outcomes
Differences in Plasma Protein Biomarker Levels Across Pancreatic Disease Groups
Time frame: At baseline (study enrollment)
Diagnostic Performance of Combined Protein Biomarkers and CA 19-9
Time frame: At baseline (study enrollment)
Diagnostic Discrimination Between Pancreatic Ductal Adenocarcinoma and Benign or Mucinous Pancreatic Conditions
Time frame: At baseline (study enrollment)
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 19 Oct 2026.
- Background1. Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021;326(9):851-862. 2. Boyd LNC, et al. Diagnostic accuracy and added value of blood-based protein biomarkers for pancreatic cancer: A meta-analysis of aggregate and individual participant data. eClinicalMedicine. 2023;55:101747. 3. Koopmann J, et al. Serum markers in patients with resectable pancreatic adenocarcinoma: macrophage inhibitory cytokine 1 versus CA19-9. Clin Cancer Res. 2006;12(2):442-446. 4. Kim Y, et al. Development and Multiple Validation of the Protein Multi-marker Panel for Diagnosis of Pancreatic Cancer. Clin Cancer Res. 2021;27(8):2236-2245. 5. Ohtsuka T, et al. International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas. Pancreatology. 2024;24(2):255-270.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations. The data will be used exclusively for the purposes of the current study, in accordance with the informed consent provided by participants and applicable data protection regulations.
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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.
Catalin V Sfarti, medical doctor, professor contact
Roxana Grigorovici principal investigator
"Grigore T. Popa" University of Medicine and Pharmacy Iasi, Romania
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 Cancer and Chronic Pancreatitis, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 5 inclusion and 5 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 19 Oct 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 Romania. 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 Roxana Grigorovici, medical doctor, PhD student (+40752082830, grigorovici.roxana@d.umfiasi.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Blood-Based Protein Biomarkers for Pancreatic Ductal Adenocarcinoma (time frame: At baseline (study enrollment, prior to oncological or interventional treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875582, which also lists 1 linked publication.
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 19 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.