Intent of Surgery for IPMN

NCT07216521 | Recruiting

• 1 other identifier: 25-00989
• Study Type: observational
• Target: 2,000
• Locations: 5 countries
• Sites: 14

Brief Summary

This multicenter retrospective observational cohort study seeks to:

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

Outcome Measures

Primary Outcomes (1)

• Grade of IPMN on Final Pathology

  Day 0 (Retrospective Analysis)

Secondary Outcomes (2)

• Recurrence Free Survival

  Day 0 (Retrospective Analysis)

• Overall Survival

  Day 0 (Retrospective Analysis)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with concomitant pancreatic ductal adenocarcinoma (PDAC)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (14)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Memorial Sloan Kettering

New York, New York, 10022, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Nanjing University

Nanjing, 210093, China

RECRUITING

Heidelberg University

Heidelberg, 69117, Germany

RECRUITING

San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Padua University

Padua, 1222, Italy

RECRUITING

University of Amsterdam

Amsterdam, 1105, Netherlands

RECRUITING

University of Utrecht

Utrecht, 3584, Netherlands

RECRUITING

Biospecimen

Retention: NONE RETAINED

This study will conduct cyst fluid analysis (CEA, amylase, DNA markers if available).

Study Officials

• Greg Sacks, MD MPH PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Hidalgo Salinas, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: September 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); CN (1); US (8); DE (1); IT (2)