Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
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)
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Jun 2017
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 7, 2017
June 1, 2017
2 years
May 10, 2017
June 5, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Two years
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.
Two years
Study Arms (2)
Patients with pancreatic cysts
ACTIVE COMPARATORFine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels
Healthy volunteers
ACTIVE COMPARATORLaboratory blood test to measure Interleukin and TNF levels
Interventions
EUS with fine-needle aspiration
Eligibility Criteria
You may qualify if:
- Patients with pancreatic cyst
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical
Hadera, 38100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2017
First Posted
June 7, 2017
Study Start
June 1, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
June 7, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share