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Hope for pancreatic cancer prevention: old drug, new trial

NCT ID NCT04207944

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether the anti-inflammatory drug sulindac can prevent high-risk pancreatic cysts (IPMNs) from progressing to pancreatic cancer. About 100 adults with these cysts will receive either sulindac or a placebo for up to 3 years, alongside standard monitoring. The goal is to see if the drug reduces cyst growth, new cysts, or cancer development.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is a man or woman between the ages of 21 and 85 (inclusive) years. 2. Subject has high-risk IPMN as defined below. 1. Patient (previously resected) has undergone partial pancreatectomy for non-invasive IPMN AND has new or residual cyst(s) \> 1 cm and/or 2. Patient (not previously resected) has a radiographic lesion of the pancreas consistent with IPMN as documented by: Cyst fluid CEA \> 192 ng/ml OR presence of GNAS or RNF 43 mutation noted in cyst fluid OR MRI imaging confirmation of "likely", "probable" or "confirmed" communication with main pancreatic duct AND at least one of the following worrisome features: * Cyst \> 2.5 cm * Thickened/enhancing cyst walls * Main pancreatic duct \> 5mm * Abrupt change in caliber of pancreatic duct with distal atrophy 3. Subjects has ECOG of 0-2 4. Subject is medically fit to undergo EUS. 5. Female subjects who are of childbearing potential or are capable of becoming pregnant must be willing to use appropriate methods of contraception for the length of the study. 6. Subject is able to provide written informed consent. Exclusion Criteria: 1. Subject has pathologic evidence of pancreatic adenocarcinoma. 2. Subject takes a systemic corticosteroid or NSAID more than 3 times per week. 3. Subject has a known history of or currently existing allergy to NSAIDs, aspirin induced asthma, gastric ulcers, non-iatrogenic intestinal perforation, or gastrointestinal bleeding from NSAID usage for which intervention was required.. 4. Subject has an ongoing history of renal insufficiency (eGFR \<50 mL/minute/1.73 m2), cardiovascular disease, gastrointestinal disorder, or any other condition that serves as a contraindication to the use of sulindac in the opinion of the treating investigator. 5. Myocardial infarction or coronary artery bypass grafting within six months of study entry. 6. Diagnosis of Congestive Heart Failure. 7. Severe adverse drug reaction to contrast agents that cannot be managed with routine premedication prior to imaging. 8. Diagnosis for (other) prior malignancy (except in situ and non-melanoma skin cancers) and are actively receiving antineoplastic or immuno therapy within 90 days of randomization. 9. History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as Roux-en-Y, prior total gastrectomy). 10. Subject is lactating or pregnant.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering

    New York, New York, 10021, United States

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