Diagnoses DiseaseNCT04536220
Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer
An observational study of Diagnoses Disease, run by Changhai Hospital at 1 site in China.
Trial summary
Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- Endoscopic Ultrasound (EUS), Fine Needle Aspiration
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jul 2026
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: All patients who meet the inclusion criteria, but not the exclusion criteria, will be included in current study. Pancreatic mass tissue samples, portal venous blood, and periferal blood will be collected for identification of potential markers for diagnosis of malignant pancreatic cancer.
Who may be able to join
- age 18-75 years,male or female
- diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- lesion diameter larger than 1 cm
- signed informed consent letter
Who cannot join
- pregnant female
- Pancreatic cystic lesions
- Anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
- Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- with history of mental disease
- other medical conditions that are not suitable for EUS-FNA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Kaixuan Wang, MD, 86-21-31161353, wangkaixuan224007@sina.com
About this study
Official title: Establish a Diagnostic Model Based on Multiple Molecule Profiling and Certain Established Markers for Identification of Pancreatic Cancer
Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass.
Read the detailed description
EUS-FNA combined cytology detection is an important method for clinical diagnosis of squamous cell carcinoma. However, due to factors such as sampling method, smear making, staining technique, lower levels of the pathologists and other factors, its diagnostic sensitivity is still not very satisfactory. Poor diagnostic efficacy usually means another puncture, longer hospital stay, more medications and a higher incidence of adverse events. Missed diagnosis continuously directly delays the treatment time of the disease and seriously affects the patient's prognosis. Therefore, how to use new technologies to improve the differential diagnosis efficiency of benign and malignant pancreatic occupants is the key to improving the prognosis of diabetic cancer patients.
The portal vein blood comes from the venous tract, including the blood flowing from the plasma to the liver. By collecting blood samples from the patient's portal vein, clinicians can separate more information from the patient. Studies have shown that the portal vein blood can be collected by ultrasound endoscopic puncture. This method is less traumatic, convenient and safe, and more information about the retinal tissue can be obtained. It is an important way to improve the efficiency of patient diagnosis. This study intends to use ultrasound endoscopic puncture technology to obtain portal vein blood, and use big data and ctDNA, metabolomics, exosomes and other different omics methods to screen the potential value of volume-occupying benign and malignant differential diagnosis markers in portal vein blood. Peripheral blood will simultaneously be collected to evaluate the efficacy of these newly developed markers.
- Conditions
- Diagnoses Disease
- Being tested
- Endoscopic Ultrasound (EUS), Fine Needle Aspiration
- Keywords
- diagnosis and pancreatic cancer
- Medical subject headings
- Disease, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound (EUS), Fine Needle AspirationDiagnostic test
Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations
| Study group | Role | What they receive |
|---|---|---|
| pancreatic mass diagnosed benign | Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with benign pancreatic mass. Receives: Diagnostic Test: Endoscopic Ultrasound (EUS), Fine Needle Aspiration | |
| pancreatic mass diagnosed malignant | Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with pancreaitic cancer. Receives: Diagnostic Test: Endoscopic Ultrasound (EUS), Fine Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of survival
To varify if the patients died becaused of malignant pancreatic cancer.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jan 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Kaixuan Wang, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536220
- Sponsor's protocol ID
- EMPVC
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2020
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within six months this study has been finished
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Diagnostic Model Based on Multiple Molecule Profiling and Certain Established Markers for Identification of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04536220
- Acronym / sponsor ID
- EMPVC
- Conditions
- Diagnoses Disease
- Keywords
- diagnosis and pancreatic cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Sep 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.
Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass.
Detailed description
EUS-FNA combined cytology detection is an important method for clinical diagnosis of squamous cell carcinoma. However, due to factors such as sampling method, smear making, staining technique, lower levels of the pathologists and other factors, its diagnostic sensitivity is still not very satisfactory. Poor diagnostic efficacy usually means another puncture, longer hospital stay, more medications and a higher incidence of adverse events. Missed diagnosis continuously directly delays the treatment time of the disease and seriously affects the patient's prognosis. Therefore, how to use new technologies to improve the differential diagnosis efficiency of benign and malignant pancreatic occupants is the key to improving the prognosis of diabetic cancer patients.
The portal vein blood comes from the venous tract, including the blood flowing from the plasma to the liver. By collecting blood samples from the patient's portal vein, clinicians can separate more information from the patient. Studies have shown that the portal vein blood can be collected by ultrasound endoscopic puncture. This method is less traumatic, convenient and safe, and more information about the retinal tissue can be obtained. It is an important way to improve the efficiency of patient diagnosis. This study intends to use ultrasound endoscopic puncture technology to obtain portal vein blood, and use big data and ctDNA, metabolomics, exosomes and other different omics methods to screen the potential value of volume-occupying benign and malignant differential diagnosis markers in portal vein blood. Peripheral blood will simultaneously be collected to evaluate the efficacy of these newly developed markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatic mass diagnosed benign | – | Diagnostic Test: Endoscopic Ultrasound (EUS), Fine Needle AspirationThrough pathological examination, radiological examination and follow-up, these patients are finally diagnosed with benign pancreatic mass. |
| pancreatic mass diagnosed malignant | – | Diagnostic Test: Endoscopic Ultrasound (EUS), Fine Needle AspirationThrough pathological examination, radiological examination and follow-up, these patients are finally diagnosed with pancreaitic cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion criteria, but not the exclusion criteria, will be included in current study. Pancreatic mass tissue samples, portal venous blood, and periferal blood will be collected for identification of potential markers for diagnosis of malignant pancreatic cancer.
Key inclusion criteria (4 listed)
- age 18-75 years,male or female
- diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- lesion diameter larger than 1 cm
- signed informed consent letter
Key exclusion criteria (8 listed)
- pregnant female
- Pancreatic cystic lesions
- Anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
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 |
|---|---|---|
| Endoscopic Ultrasound (EUS), Fine Needle AspirationEndoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations | Diagnostic test | pancreatic mass diagnosed benign, pancreatic mass diagnosed malignant |
Primary outcome
Status of survival
Time frame: through study completion, an average of 1 year
To varify if the patients died becaused of malignant pancreatic cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No. Within six months this study has been finished
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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.
Kaixuan Wang, MD principal investigator
Changhai Hospital
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 Diagnoses Disease, run by Changhai Hospital 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 4 inclusion and 8 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 29 Mar 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 Xiangyu Kong, MD (13564644397, xiangyukong185@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of survival (time frame: through study completion, an average of 1 year). 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 29 Mar 2024.