Intraductal Papillary Mucinous NeoplasmNCT07216521
Intent of Surgery for IPMN
An observational study of Intraductal Papillary Mucinous Neoplasm, run by NYU Langone Health at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm
- How many people
- 2,000 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 15 Sep 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Patients with concomitant pancreatic ductal adenocarcinoma (PDAC)
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jin He, MD, PhD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Carlos Fernandez-del Castillo, MD
- Recruiting
Duke University
Durham, North Carolina, 27710
Daniel Nussbaum, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Michael Kim, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Greg Sacks, MD MPH PhD
- Recruiting
Memorial Sloan Kettering
New York, New York, 10022
Kevin Soares, MD
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Zhi Fong, MD, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Cornelius Thiels, D.O., MBA
Italy2 sites, 2 recruiting
- Recruiting
San Raffaele Hospital
Milan, 20132
Massimo Falconi, MD
- Recruiting
Padua University
Padua, 1222
Giovanni Marchegiani, MD, PhD
Netherlands2 sites, 2 recruiting
- Recruiting
University of Amsterdam
Amsterdam, 1105
Marc Besselink, MD MsC PhD
- Recruiting
University of Utrecht
Utrecht, 3584
Lois Daamen, MD, PhD
China1 site, 1 recruiting
- Recruiting
Nanjing University
Nanjing, 210093
Yi Miao, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University
Heidelberg, 69117
Martin Loos, MD
About this study
Official title: Optimizing Preoperative Surgical Decision-making for Intraductal Papillary Mucinous Neoplasms: The Role of Intent of Surgery
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).
- Conditions
- Intraductal Papillary Mucinous Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of IPMN on Final Pathology
Measured: Day 0 (Retrospective Analysis)
Secondary outcomes (2)
Recurrence Free Survival
Length of time from surgery for IPMN to recurrence.
Measured: Day 0 (Retrospective Analysis)
Overall Survival
Length of time from surgery to death due to any cause.
Measured: Day 0 (Retrospective Analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start15 Sep 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraductal Papillary Mucinous NeoplasmStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Sacks, MD MPH PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216521
- Sponsor's protocol ID
- 25-00989
- Status last verified
- Oct 2025
- First submitted
- 9 Oct 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Multicenter collaboration limited by data use agreements between institutions for multicenter data to be used solely for study in question.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Preoperative Surgical Decision-making for Intraductal Papillary Mucinous Neoplasms: The Role of Intent of Surgery
- ClinicalTrials.gov ID
- NCT07216521
- Acronym / sponsor ID
- 25-00989
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with concomitant pancreatic ductal adenocarcinoma (PDAC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade of IPMN on Final Pathology
Time frame: Day 0 (Retrospective Analysis)
2 secondary outcomes
Recurrence Free Survival
Time frame: Day 0 (Retrospective Analysis)
Overall Survival
Time frame: Day 0 (Retrospective Analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No. Multicenter collaboration limited by data use agreements between institutions for multicenter data to be used solely for study in question.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greg Sacks, MD MPH PhD principal investigator
NYU Langone Health
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraductal Papillary Mucinous Neoplasm, run by NYU Langone Health at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Italy, Netherlands, China, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camila Hidalgo Salinas, MD (347-266-1376, Camila.hidalgosalinas@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of IPMN on Final Pathology (time frame: Day 0 (Retrospective Analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.