Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Pancreas Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855800
• Other study ID #: 17-008436
• Secondary ID: 2U01CA210138
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: December 2030

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: IN-CYST Team
• Phone: 1-833-250-5364
• Email: rstincyststudy[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Pancreas Cyst
• Pancreatic Cyst

Intervention

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
• Endoscopy Exam
Clinically indicated endoscopic ultrasound

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biospecimen Acquisition	Number of biospecimens collected	5 years
Primary	High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group	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	5 years
Secondary	High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group	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	5 years

External Links

•   Mayo Clinic Clinical Trials