RecruitingNot ApplicableNCT03855800

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

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


Sponsor

Mayo Clinic

Enrollment

800 participants

Start Date

May 11, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether analyzing fluid and tissue samples taken from pancreatic cysts (fluid-filled sacs in the pancreas) during a routine procedure can help identify which cysts are likely to turn cancerous, in order to guide better surgical and monitoring decisions. **You may be eligible if...** - You have pancreatic cysts that meet specific concerning criteria (called Fukuoka worrisome features or high-risk stigmata) on imaging - You are suspected to have a cystic (fluid-filled) tumor of the pancreas - You are able to give written informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are incarcerated - Imaging already suggests an existing pancreatic cancer - You have a prior history of pancreatic cancer or previous pancreatic surgery - You have received chemotherapy or abdominal radiation in the past 5 years - You have had a previous procedure to treat a pancreatic cyst - You have a history of pancreatic necrosis (tissue death in the pancreas) - You have had a cancer diagnosis (other than non-melanoma skin cancer) in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood, 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.

PROCEDUREPancreatic Surgery

Surgical resection of pancreatic cyst

PROCEDUREEndoscopy Exam

Clinically indicated endoscopic ultrasound


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT03855800


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