Serum TAM Receptor Tyrosine Kinase Ligands in Acute Pancr... | NCT07023055

Studies
Serum TAM Receptor Tyrosine Kinase Ligands in Acute Pancreatitis

NCT07023055

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Jun 22, 2025Actual

Enrollment

896Actual

Phase

Not provided

Conditions

Acute Pancreatic Necrosis
Acute Pancreatitis (AP)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Mar 1, 2025Actual

Completion Date

Mar 1, 2025Actual

First Submitted Date

Jun 8, 2025

First Submission Date that Met QC Criteria

Jun 8, 2025

First Posted Date

Jun 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2025

Last Update Posted Date

Jun 22, 2025Actual

Name	Class
The first affiliated Hospital of Nanjing Medical University, Jiangsu Province	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

896Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 days

Secondary Outcomes

Measure	Description	Time Frame
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).	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80 years.
Patients diagnosed with acute pancreatitis in outpatient/emergency departments, inpatient wards, or health examination centers starting from 2024.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Description

No, we do not plan to share individual participant data due to privacy regulations and ethical considerations.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided