Clinical trial Recruiting at 1 site Interventional Ages 18 to 120

Detecting cancer risk in pancreatic cysts using new tests

Official title: Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)

Run by Mayo Clinic · NCT03855800 · Data updated 2026-11-12

This study is testing new blood and fluid tests to see if they can help identify cancer risks in people with certain types of pancreatic cysts.

Quick facts

Study typeInterventional
Ages18 Years to 120 Years
SexAll
Enrollment800 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedMay 11, 2018
Main results expectedDecember 30, 2030
Study endsDecember 30, 2030
Registry record updatedJune 2, 2026
Trial IDNCT03855800 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with pancreatic cystic lesions classified as Fukuoka worrisome or high-risk.

Probably not a fit

Patients with a prior history of pancreatic cancer or those currently diagnosed with other cancers may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of new biomarkers found in blood, stool, pancreatic cyst fluid, and pancreatic juice for diagnosing malignant or pre-malignant changes in pancreatic cysts. Participants with Fukuoka Worrisome or Fukuoka High Risk pancreatic cysts will be enrolled and assigned to either Immediate Surgery or Clinical Follow-up groups based on their clinical management. Specimens will be collected from participants to assess the presence of these biomarkers and their correlation with cyst malignancy. The study is designed to improve diagnostic accuracy and patient outcomes in managing pancreatic cysts.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of cancerous changes in pancreatic cysts, potentially improving patient outcomes.

How similar studies have gone: Other studies have explored similar biomarker approaches in cancer detection, showing promising results, but this specific application in pancreatic cysts is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
* Patients with suspected cystic neoplasm of the pancreas
* Able to provide written informed consent

Exclusion Criteria:

* Pregnant and/or nursing
* Incarceration
* Imaging showing possible pancreatic cancer
* Prior history of pancreatic cancer or pancreatic surgery
* History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
* Previous therapy for a pancreatic cystic lesion
* History of pancreatic necrosis
* Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years

Where it's running

  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.