Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

NCT03855800 | Recruiting

• 2 other identifiers: 17-0084362U01CA210138
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Biospecimen Acquisition

  Number of biospecimens collected

  5 years

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

  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

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (2)

Clinical Follow-up

EXPERIMENTAL

Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted

Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Endoscopy Exam

Surgical

OTHER

Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.

Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Pancreatic Surgery

Interventions

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.

Clinical Follow-up; Surgical

Pancreatic Surgery PROCEDURE

Surgical resection of pancreatic cyst

Surgical

Endoscopy Exam PROCEDURE

Clinically indicated endoscopic ultrasound

Clinical Follow-up

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Shounak Majumder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IN-CYST Team

CONTACT

1-833-250-5364; rstincyststudy@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 27, 2019
• Study Start: May 11, 2018
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)