Pancreatic Ductal AdenocarcinomaNCT06041009
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
An observational study of Pancreatic Ductal Adenocarcinoma and Pancreatic Diseases, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1
- What is being tested?
- Pancreatic elastase-1 in blood serum
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pancreatic cancer patients at high risk, patients with pancreatic cancer, benign pancreatic disease, borderline malignant disease, and abnormal elevation of CA199, as well as patients with other diseases without pancreatic disease are included. The Pancreatic cancer patients at high risk are those which are hereditary pancreatic cancer patients at high risk, chronic pancreatitis, new diabetes mellitus, or PCN pancreatic cystic tumor patients.
Who may be able to join
- Case groups (matching any of the following):
- Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
- Patients who are the high-risk group of pancreatic cancer.
- Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
- Patients with other diseases with abnormally elevated CA19-9.
- Control group:
- Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
Who cannot join
- Patients who are younger than 18 years of age.
- Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
- Patients who have not signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ning Zhong
Jinan, Shandong, 250063
Ning Zhong, MD
Zhen Li, MD, 18560086106, qilulizhen@sdu.edu.cn
About this study
Official title: Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1, Pancreatic Neuroendocrine Tumor, Pancreatitis, Pancreatic Neoplasms
- Being tested
- Pancreatic elastase-1 in blood serum
- Medical subject headings
- Pancreatic Diseases, Adenoma, Islet Cell, Pancreatitis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic elastase-1 in blood serumDiagnostic test
Also called Multiomics in blood serum or tissue
Serum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PDAC | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum | |
| Individuals at high risk for PDAC | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum | |
| Group of neuroendocrine neoplasm of pancreas | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum | |
| Group of solid pseudopapillary tumor of pancreas | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum | |
| Group of abnormally elevated CA19-9 | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum | |
| Controls without pancreatic disease or elevated CA19-9 | Not described Receives: Diagnostic Test: Pancreatic elastase-1 in blood serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
Measured: 2 years
Secondary outcomes (4)
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.
Measured: 2 years
The content of elastase 1
The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)
Measured: 2 years
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease.
Measured: 2 years
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start5 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, LanZhou University
- Responsible party
- Sponsor
- Investigators
- Ning Zhong, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041009
- Sponsor's protocol ID
- 2023SDU-QILU-4
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
- ClinicalTrials.gov ID
- NCT06041009
- Acronym / sponsor ID
- 2023SDU-QILU-4
- Conditions
- Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1, Pancreatic Neuroendocrine Tumor, Pancreatitis, Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, LanZhou University
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with PDAC | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
| Individuals at high risk for PDAC | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
| Group of neuroendocrine neoplasm of pancreas | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
| Group of solid pseudopapillary tumor of pancreas | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
| Group of abnormally elevated CA19-9 | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
| Controls without pancreatic disease or elevated CA19-9 | – | Diagnostic Test: Pancreatic elastase-1 in blood serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients at high risk, patients with pancreatic cancer, benign pancreatic disease, borderline malignant disease, and abnormal elevation of CA199, as well as patients with other diseases without pancreatic disease are included. The Pancreatic cancer patients at high risk are those which are hereditary pancreatic cancer patients at high risk, chronic pancreatitis, new diabetes mellitus, or PCN pancreatic cystic tumor patients.
Key inclusion criteria (7 listed)
- Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
- Patients who are the high-risk group of pancreatic cancer.
- Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
- Patients with other diseases with abnormally elevated CA19-9.
- Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
Key exclusion criteria (3 listed)
- Patients who are younger than 18 years of age.
- Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
- Patients who have not signed informed consent.
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 |
|---|---|---|
| Pancreatic elastase-1 in blood serumAlso: Multiomics in blood serum or tissueSerum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form. | Diagnostic test | Controls without pancreatic disease or elevated CA19-9, Group of abnormally elevated CA19-9, Group of neuroendocrine neoplasm of pancreas, Group of solid pseudopapillary tumor of pancreas, Individuals at high risk for PDAC, Patients with PDAC |
Primary outcome
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
Time frame: 2 years
The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
4 secondary outcomes
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
Time frame: 2 years
The content of elastase 1
Time frame: 2 years
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
Time frame: 2 years
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ning Zhong, MD principal investigator
Qilu Hospital of Shandong University
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 Ductal Adenocarcinoma and Pancreatic Diseases, run by Qilu Hospital of Shandong University at 1 site in China.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li, MD (18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) (time frame: 2 years). 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 18 Oct 2024.