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Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

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ClinicalTrials.gov Identifier: NCT03855800
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Shounak Majumder, Mayo Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2026

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, 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

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 know.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855800


Contacts
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Contact: Sarah Amundson 507-266-2852 amundson.sarah@mayo.edu
Contact: Casi Bell 507-293-0202 bell.cassandra@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah Amundson    507-266-2852    amundson.sarah@mayo.edu   
Contact: Casi Bell    507-293-0202    bell.cassandra@mayo.edu   
Principal Investigator: Shounak Majumder, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shounak Majumder, MD Mayo Clinic

Additional Information:
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Responsible Party: Shounak Majumder, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03855800     History of Changes
Other Study ID Numbers: 17-008436
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases