Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

NCT03855800 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-12-17

No results posted yet for this study

Summary

Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.

Conditions

  • Pancreas Cyst

Interventions

DIAGNOSTIC_TEST

Blood, stool, pancreatic juice and cyst fluid collection

Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.

PROCEDURE

Pancreatic Surgery

Surgical resection of pancreatic cyst

PROCEDURE

Endoscopy Exam

Clinically indicated endoscopic ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Shounak Majumder, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2030-12-30
Completion
2030-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855800 on ClinicalTrials.gov