Intent of Surgery for IPMN

NCT ID: NCT07216521

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2025-12-31

Brief Summary

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This multicenter retrospective observational cohort study seeks to:

1. 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.
2. Compare clinicopathologic features and outcomes between surveillance-detected and incidentally detected IPMN-derived pancreatic cancers.
3. 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

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Conditions

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Intraductal Papillary Mucinous Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greg Sacks, MD MPH PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering

New York, New York, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Nanjing University

Nanjing, , China

Site Status RECRUITING

Heidelberg University

Heidelberg, , Germany

Site Status RECRUITING

San Raffaele Hospital

Milan, , Italy

Site Status RECRUITING

Padua University

Padua, , Italy

Site Status RECRUITING

University of Amsterdam

Amsterdam, , Netherlands

Site Status RECRUITING

University of Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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United States China Germany Italy Netherlands

Central Contacts

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Camila Hidalgo Salinas, MD

Role: CONTACT

347-266-1376

Other Identifiers

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25-00989

Identifier Type: -

Identifier Source: org_study_id

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