Pancreas Cyst
Conditions
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.
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.
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
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTIN-CYST Team
PRINCIPAL_INVESTIGATORShounak Majumder, MD
Mayo Clinic
Outcome results
None listed