Pancreatic Juice Diagnosis From Duodenum
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tumor markers
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Common inclusion criterion
- Age is 18 years or older.
- Informed consent was obtained.
- Inclusion criterion for normal cohort
- An upper GI endoscopy is scheduled to check upper abdominal symptoms.
- No findings of pancreatic disorder as documented by CT or MRI or EUS
- Inclusion criterion for PC suspicious cohort
- A EUS or ERCP is scheduled to suspected pancreatic disorder.
Exclusion Criteria:
- Common exclusion criterion
- Severe cardiac disease
- Severe respiratory disease
- Bleeding disorders
- Pregnancy
Sites / Locations
- Mayo Clinic Jacksonville
- Kyushu University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test subject
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)
Full Information
NCT ID
NCT01699698
First Posted
September 24, 2012
Last Updated
September 2, 2015
Sponsor
Olympus Corporation
Collaborators
Mayo Clinic, Kyushu University, The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT01699698
Brief Title
Pancreatic Juice Diagnosis From Duodenum
Official Title
Pancreatic Juice Diagnosis From Duodenum
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation
Collaborators
Mayo Clinic, Kyushu University, The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient.
The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
Pancreatic adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test subject
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Tumor markers
Intervention Description
Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.
Primary Outcome Measure Information:
Title
The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
Description
We hypothesized that there is a statistically-significant difference between two cohorts.
The cancer marker is S100P.
Time Frame
1year
Secondary Outcome Measure Information:
Title
The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
Description
Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Common inclusion criterion
Age is 18 years or older.
Informed consent was obtained.
Inclusion criterion for normal cohort
An upper GI endoscopy is scheduled to check upper abdominal symptoms.
No findings of pancreatic disorder as documented by CT or MRI or EUS
Inclusion criterion for PC suspicious cohort
A EUS or ERCP is scheduled to suspected pancreatic disorder.
Exclusion Criteria:
Common exclusion criterion
Severe cardiac disease
Severe respiratory disease
Bleeding disorders
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Raimondo, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Kyushu University
City
Fukuoka-shi
State/Province
Fukuoka-ken
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
17912013
Citation
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.
Results Reference
background
Learn more about this trial
Pancreatic Juice Diagnosis From Duodenum
We'll reach out to this number within 24 hrs