Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
IN-CYST Team
rstincyststudy@mayo.edu
1-833-250-5364
Time Frame
Start Date: 2018-05-11
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 800
Treatments
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 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
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)