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NCT Number: NCT03855800

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

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.

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Key information

Conditions

Pancreas Cyst Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

IN-CYST Team

CONTACT

[email protected]

833-250-5364 ext. 2

Shounak Majumder, MD

PRINCIPAL_INVESTIGATOR

About this study

Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood, stool, pancreatic juice and cyst fluid collection

Diagnostic Test

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.

Pancreatic surgery

Procedure

Surgical resection of pancreatic cyst

Endoscopy Exam

Procedure

Clinically indicated endoscopic ultrasound

Primary outcomes

  1. Biospecimen Acquisition

    Time frame: 5 years

    Number of biospecimens collected

  2. High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group

    Time frame: 5 years

    To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection

Secondary outcomes

  1. High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group

    Time frame: 5 years

    To evaluate the performance of cyst fluid MDM assays for predicting development of HGD or cancer during 3-year follow-up in study patients who are initially managed non-operatively

Study contacts

Contact information is provided by the study sponsor or research team.

IN-CYST Team

CONTACT

[email protected]

1-833-250-5364 ext. 2

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Feb 27, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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