Diagnostic Prediction of Pancreatic Masses | NCT06724055

Studies
Diagnostic Prediction of Pancreatic Masses

NCT06724055

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Dec 9, 2024Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Pancreatic Masses

Interventions

Not provided

Countries

Not provided

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

Nov 2024

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, 2002Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

May 31, 2023Actual

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Dec 6, 2024

First Posted Date

Dec 9, 2024Actual

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

Dec 6, 2024

Last Update Posted Date

Dec 9, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. The main question it aims to answer is:

What features, in the perspectives of clinical manifestation, laboratory tests, and imaging, can differentiate different kinds of pancreatic masses (AIP, PPL and PDAC)?

Participants will not be given any interventions since this is a retrospective observational study.

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

110Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic nomogram		From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Secondary Outcomes

Measure	Description	Time Frame
serum level of LDH		From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
serum level of IgG4		From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inpatients presenting with pancreatic masses and eventually diagnosed with PPL, AIP, or PDAC (confirmed by pathologic results).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Inpatients in Peking Union Medical College Hospital.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
AIP
PPL
PDAC