Pancreatic Juice Diagnosis From Duodenum
1 other identifier
interventional
105
2 countries
2
Brief Summary
Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
2 active sites
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
September 24, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedResults Posted
Study results publicly available
September 3, 2015
CompletedSeptember 21, 2015
September 1, 2015
1.7 years
September 24, 2012
June 30, 2015
September 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
We hypothesized that there is a statistically-significant difference between two cohorts. The cancer marker is S100P.
1year
Secondary Outcomes (1)
The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
1 year
Study Arms (1)
Test subject
EXPERIMENTALInterventions
Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.
Eligibility Criteria
You may qualify if:
- Age is 18 years or older.
- Informed consent was obtained.
- An upper GI endoscopy is scheduled to check upper abdominal symptoms.
- No findings of pancreatic disorder as documented by CT or MRI or EUS
- A EUS or ERCP is scheduled to suspected pancreatic disorder.
You may not qualify if:
- Severe cardiac disease
- Severe respiratory disease
- Bleeding disorders
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olympus Corporationlead
- Mayo Cliniccollaborator
- Kyushu Universitycollaborator
- The University of Texas Health Science Center, Houstoncollaborator
Study Sites (2)
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Kyushu University
Fukuoka, Fukuoka, Japan
Related Publications (1)
Pungpapong S, Noh KW, Woodward TA, Wallace MB, Al-Haddad M, Raimondo M. Endoscopic ultrasound and IL-8 in pancreatic juice to diagnose chronic pancreatitis. Pancreatology. 2007;7(5-6):491-6. doi: 10.1159/000108966. Epub 2007 Oct 1.
PMID: 17912013BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Taketo Matsunaga
- Organization
- Kyushu University
Study Officials
- PRINCIPAL INVESTIGATOR
Massimo Raimondo, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2012
First Posted
October 4, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2014
Last Updated
September 21, 2015
Results First Posted
September 3, 2015
Record last verified: 2015-09