Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)

June 5, 2017 updated by: Hillel Yaffe Medical Center

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)

This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • H̱adera, Israel, 38100
        • Hillel Yaffe Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with pancreatic cyst

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Patients with pancreatic cysts
Fine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels
Procedure: EUS with fine-needle aspiration of pancreatic cyst
EUS with fine-needle aspiration
ACTIVE_COMPARATOR: Healthy volunteers
Laboratory blood test to measure Interleukin and TNF levels
Procedure: EUS with fine-needle aspiration of pancreatic cyst
EUS with fine-needle aspiration
Diagnostic test: Laboratory Blood test
Laboratory Blood Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
Time Frame: Two years
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.
Two years
Prediction of malignant potential of pancreatic cyst by measuring TNF levels
Time Frame: Two years
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (ACTUAL)

June 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0018-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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