Early Detection of PDAC in Patients With Chronic Pancreat... | NCT07104864

Studies
Early Detection of PDAC in Patients With Chronic Pancreatitis

NCT07104864

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Completed

Last Update Posted

Aug 5, 2025Actual

Enrollment

359Actual

Phase

Not provided

Conditions

Chronic Pancreatitis
PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

histopathological confirmation

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

Jul 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

Aug 1, 2024Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 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

Jul 29, 2025

Last Update Posted Date

Aug 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The goal of this study is to find simple warning signs that doctors can use to spot pancreatic cancer early in people who have chronic pancreatitis.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

359Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
histopathological confirmation	Diagnostic Test	histopathological confirmation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pathological diagnosis of PDAC		January 2013 and December 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a confirmed diagnosis of chronic pancreatitis; (2) availability of pathological confirmation.

Exclusion Criteria:

age less than 18 years; (2) ambiguous pathology, including cases with only cytological findings or indications of pancreatic tissue alone; (3) preoperative diagnosis of PDAC or other pancreatic tumors before invasive procedure; (4) presence of tumors in other organs; (5) patients with missing data exceeding 15% of the total dataset.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with CP upon admission to the First Affiliated Hospital of Xi'an Jiaotong University between January 2013 and December 2023

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Xi'an Jiaotong University		Xi'an	Shaanxi	710061	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided