Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07216521

Conditions

Intraductal Papillary Mucinous Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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).

Conditions

Intraductal Papillary Mucinous Neoplasm

Study ID

NCT07216521

Start date

Sep 15, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Grade of IPMN on Final Pathology [ Time Frame: Day 0 (Retrospective Analysis) ]

Central Contacts and Locations

Central contacts

Camila Hidalgo Salinas, MD

347-266-1376Camila.hidalgosalinas@nyulangone.org

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Principal Investigator:

Zhi Fong, MD, PhD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Jin He, MD, PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Carlos Fernandez-del Castillo, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Cornelius Thiels, D.O., MBA

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Greg Sacks, MD MPH PhD

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10022

Principal Investigator:

Kevin Soares, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Daniel Nussbaum, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Michael Kim, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-10-14.