Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03855800

Collaborator

(none)

800

Enrollment

Location

Arms

103.7

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cyst	Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection Procedure: Pancreatic Surgery Procedure: Endoscopy Exam	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 11, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinical Follow-up 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 3 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 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: Endoscopy Exam Clinically indicated endoscopic ultrasound
Other: Surgical 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 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

Arm

Intervention/Treatment

Experimental: Clinical Follow-up

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 3 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

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: Endoscopy Exam

Clinically indicated endoscopic ultrasound

Other: Surgical

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

Surgical resection of pancreatic cyst

Outcome Measures

Primary Outcome Measures

Biospecimen Acquisition [5 years]
Number of biospecimens collected
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
Patients with suspected cystic neoplasm of the pancreas
18 years or old
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Shounak Majumder, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Shounak Majumder, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03855800

Other Study ID Numbers:

17-008436

First Posted:

Feb 27, 2019

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cysts

Pancreatic Cyst

Study Results

No Results Posted as of Jan 3, 2022