Clinicopathologic Characteristics, Progression, and Progn... | NCT06887023

Studies
Clinicopathologic Characteristics, Progression, and Prognostic Analysis of IPNB

NCT06887023

Sponsor

The First Hospital of Jilin University

Status

Completed

Last Update Posted

Mar 20, 2025Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Bile Duct Neoplasms Malignant

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

Feb 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

Dec 1, 2024Actual

Primary Completion Date

Jan 15, 2025Actual

Completion Date

Feb 1, 2025Actual

First Submitted Date

Mar 14, 2025

First Submission Date that Met QC Criteria

Mar 14, 2025

First Posted Date

Mar 20, 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

Mar 14, 2025

Last Update Posted Date

Mar 20, 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 main aim of this observational study is to understand the clinicopathological and prognostic information of IPNB, a rare tumor. The participants have already received treatment during their previous routine medical management and took part in follow - up. We will look into their survival information after previous medical visits and treatment.

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

118Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death	Died of various causes after treatment	From January 2014 to June 2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IPNB with or without malignant transformation was confirmed by pathological examination

Exclusion Criteria:

missing other essential clinical data
coexisting malignant tumors of other digestive system organs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with IPNB from eight Chinese hospitals over a 10-year period

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 Hospital of Jilin University		Changchun	Jililn	130000	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D018450	Disease Progression

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided