Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood, stool, pancreatic juice and cyst fluid collection, Pancreatic Surgery, Endoscopy Exam.
- Who it may be relevant to
- Registry conditions: Pancreas Cyst. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
Overview
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 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 proc - Procedure Pancreatic Surgery
Surgical resection of pancreatic cyst - Procedure Endoscopy Exam
Clinically indicated endoscopic ultrasound
Primary outcome measures
- Biospecimen Acquisition [Time frame: 5 years]
- High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group [Time frame: 5 years]
Secondary outcome measures (1)
- High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT03855800 · 17-008436 · 2U01CA210138