Acute Pancreatic NecrosisNCT07023055
Serum TAM Receptor Tyrosine Kinase Ligands in Acute Pancreatitis
An observational study of Acute Pancreatic Necrosis and Acute Pancreatitis (AP), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
AXL and MERTK are homologous members of the TAM (TYRO3, AXL, MERTK) receptor tyrosine kinase family. They function as critical regulators of antiviral immunity, autoimmune responses, and tumor microenvironment modulation through their bridging ligands, GAS6 (Growth Arrest-Specific 6) and PROS1 (Protein S). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatic Necrosis, Acute Pancreatitis (AP)
- How many people
- 896 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Mar 2025
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed with AP based on at least two of the following criteria (1) acute onset of upper abdominal pain; (2) more than three times the upper limit of the normal range of serum lipase or amylase levels; and (3) typical radiological findings of AP on computed tomography (CT), magnetic resonance imaging, or ultrasonography.
Who may be able to join
- Age 18-80 years.
- Patients diagnosed with acute pancreatitis in outpatient/emergency departments, inpatient wards, or health examination centers starting from 2024.
Who cannot join
- Patients with chronic pancreatitis or pancreatic cancer.
- Pregnant or lactating women.
- Patients who did not provide informed consent.
- Patients with severe organic diseases, such as malignant tumors, acute myocardial infarction, or large-scale cerebral infarction.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Multicenter Prospective Cohort Study on TAM Receptor Tyrosine Kinase Ligands for Predicting the Severity of Acute Pancreatitis
AXL and MERTK are homologous members of the TAM (TYRO3, AXL, MERTK) receptor tyrosine kinase family. They function as critical regulators of antiviral immunity, autoimmune responses, and tumor microenvironment modulation through their bridging ligands, GAS6 (Growth Arrest-Specific 6) and PROS1 (Protein S). These receptors serve as damage sensors that negatively regulate inflammation, promote tissue repair/remodeling, and modulate fibrotic processes in chronic inflammatory conditions. Building upon our previous work demonstrating the pivotal role of the AXL/MERTK signaling axis in AP pathogenesis - particularly in pancreatic necrosis regulation, this clinical study seeks to evaluate the prognostic value of the TAM receptor ligands GAS6 and PROS1 as biomarkers for predicting AP severity.
- Conditions
- Acute Pancreatic Necrosis, Acute Pancreatitis (AP)
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Severe Acute Pancreatitis
AP severity was classified as mild (MAP), moderately severe (MSAP), or severe (SAP) according to the revised Atlanta classification.
Measured: 2 days
Secondary outcomes (1)
Incidence Rate of Persistent Organ Failure (≥48 Hours) in Acute Pancreatitis
Organ dysfunction in acute pancreatitis refers to the impairment of one or more organ systems (e.g., respiratory, renal, cardiovascular) due to systemic inflammation, often leading to persistent organ failure (≥48 hours), a hallmark of severe acute pancreatitis (SAP).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatic NecrosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 896 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The first affiliated Hospital of Nanjing Medical University, Jiangsu Province
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023055
- Sponsor's protocol ID
- 2024-SR-958
- Status last verified
- Jan 2025
- First submitted
- 8 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan to share individual participant data due to privacy regulations and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study on TAM Receptor Tyrosine Kinase Ligands for Predicting the Severity of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT07023055
- Acronym / sponsor ID
- 2024-SR-958
- Conditions
- Acute Pancreatic Necrosis, Acute Pancreatitis (AP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The first affiliated Hospital of Nanjing Medical University, Jiangsu Province
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Jun 2025 (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.
AXL and MERTK are homologous members of the TAM (TYRO3, AXL, MERTK) receptor tyrosine kinase family. They function as critical regulators of antiviral immunity, autoimmune responses, and tumor microenvironment modulation through their bridging ligands, GAS6 (Growth Arrest-Specific 6) and PROS1 (Protein S). These receptors serve as damage sensors that negatively regulate inflammation, promote tissue repair/remodeling, and modulate fibrotic processes in chronic inflammatory conditions. Building upon our previous work demonstrating the pivotal role of the AXL/MERTK signaling axis in AP pathogenesis - particularly in pancreatic necrosis regulation, this clinical study seeks to evaluate the prognostic value of the TAM receptor ligands GAS6 and PROS1 as biomarkers for predicting AP severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with AP based on at least two of the following criteria (1) acute onset of upper abdominal pain; (2) more than three times the upper limit of the normal range of serum lipase or amylase levels; and (3) typical radiological findings of AP on computed tomography (CT), magnetic resonance imaging, or ultrasonography.
Key inclusion criteria (2 listed)
- Age 18-80 years.
- Patients diagnosed with acute pancreatitis in outpatient/emergency departments, inpatient wards, or health examination centers starting from 2024.
Key exclusion criteria (4 listed)
- Patients with chronic pancreatitis or pancreatic cancer.
- Pregnant or lactating women.
- Patients who did not provide informed consent.
- Patients with severe organic diseases, such as malignant tumors, acute myocardial infarction, or large-scale cerebral infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Participants with Severe Acute Pancreatitis
Time frame: 2 days
AP severity was classified as mild (MAP), moderately severe (MSAP), or severe (SAP) according to the revised Atlanta classification.
1 secondary outcome
Incidence Rate of Persistent Organ Failure (≥48 Hours) in Acute Pancreatitis
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No. No, we do not plan to share individual participant data due to privacy regulations and ethical considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Pancreatic Necrosis and Acute Pancreatitis (AP), run by Peking Union Medical College 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Severe Acute Pancreatitis (time frame: 2 days). 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 2025.