Intent of Surgery for IPMN | NCT07216521

Studies
Intent of Surgery for IPMN

NCT07216521

Sponsor

NYU Langone Health

Status

Recruiting

Last Update Posted

Oct 14, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Intraductal Papillary Mucinous Neoplasm

Interventions

Not provided

Countries

United States
China
Germany
Italy
Netherlands

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Oct 9, 2025

First Submission Date that Met QC Criteria

Oct 9, 2025

First Posted Date

Oct 14, 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

Oct 9, 2025

Last Update Posted Date

Oct 14, 2025Actual

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

This multicenter retrospective observational cohort study seeks to:

Classify surgical intent in patients with resected Intraductal Papillary Mucinous Neoplasms (IPMN) and quantify the proportion of IPMN-associated cancers diagnosed as overt pancreatic cancer with incidental IPMN association on pathology.
Compare clinicopathologic features and outcomes between surveillance-detected and incidentally detected IPMN-derived pancreatic cancers.
Revise and redefine risk features limited to patients undergoing surgery for IPMN-related indications, identifying optimal predictors of malignant IPMN (high-grade dysplasia or invasive cancer).

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

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who underwent surgical resection for IPMN		Pathology reports on patients (18 years old of greater) who underwent surgical resection for IPMN will be accessed for analysis.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Grade of IPMN on Final Pathology		Day 0 (Retrospective Analysis)

Secondary Outcomes

Measure	Description	Time Frame
Recurrence Free Survival	Length of time from surgery for IPMN to recurrence.	Day 0 (Retrospective Analysis)
Overall Survival	Length of time from surgery to death due to any cause.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients (18 years old of greater) who underwent surgical resection for IPMN (including low-, high-grade dysplasia, or invasive carcinoma) between July 1, 2015 and July 1, 2025.

Exclusion Criteria:

Patients with concomitant pancreatic ductal adenocarcinoma (PDAC)

Accepts Healthy Volunteers

Not provided

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 (18 years old of greater) who underwent surgical resection for IPMN (including low-, high-grade dysplasia, or invasive carcinoma) between July 1, 2015 and July 1, 2025.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Camila Hidalgo Salinas, MD	Contact	347-266-1376		Camila.hidalgosalinas@nyulangone.org

Overall Officials

Name	Affiliation	Role
Greg Sacks, MD MPH PhD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Phoenix	Arizona	85054	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Multicenter collaboration limited by data use agreements between institutions for multicenter data to be used solely for study in question.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided