Back to resultsRole of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EUS with fine-needle aspiration of pancreatic cyst
Laboratory Blood test
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with pancreatic cyst
Exclusion Criteria:
- None
Sites / Locations
- Hillel Yaffe Medical
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with pancreatic cysts
Healthy volunteers
Arm Description
Fine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels
Laboratory blood test to measure Interleukin and TNF levels
Outcomes
Primary Outcome Measures
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
Interleukin 1,8,10 will be measured quantitatively by an enzyme-linked immunosorbent assay. The same interleukins levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Prediction of malignant potential of pancreatic cyst by measuring TNF levels
TNF levels will be measured quantitatively by an enzyme-linked immunosorbent assay. The same TNF levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03178812
Brief Title
Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
Official Title
The Role of the Cystic Fluid Interleukins 1,8, & 10 and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One arm containing patients with pancreatic lesion and one control group arm of healthy volunteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with pancreatic cysts
Arm Type
Active Comparator
Arm Description
Fine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Laboratory blood test to measure Interleukin and TNF levels
Intervention Type
Procedure
Intervention Name(s)
EUS with fine-needle aspiration of pancreatic cyst
Intervention Description
EUS with fine-needle aspiration
Intervention Type
Diagnostic Test
Intervention Name(s)
Laboratory Blood test
Intervention Description
Laboratory Blood Test
Primary Outcome Measure Information:
Title
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
Description
Interleukin 1,8,10 will be measured quantitatively by an enzyme-linked immunosorbent assay. The same interleukins levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Time Frame
Two years
Title
Prediction of malignant potential of pancreatic cyst by measuring TNF levels
Description
TNF levels will be measured quantitatively by an enzyme-linked immunosorbent assay. The same TNF levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with pancreatic cyst
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Kopelman, MD
Phone
972-50-6246840
Email
yaelk@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical
City
H̱adera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yael Kopelman, MD
Phone
972-50-6246840
Email
yaelk@hy.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
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