Pancreatic Juice Diagnosis From Duodenum

September 2, 2015 updated by: Olympus Corporation
Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

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

  • Japan
    • Fukuoka-ken
      • Fukuoka-shi, Fukuoka-ken, Japan
        • Kyushu University
  • United States
    • Florida
      • Jacksonville, Florida, United States
        • Mayo Clinic Jacksonville

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

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test subject
Other: Tumor markers
Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
Time Frame: 1year

We hypothesized that there is a statistically-significant difference between two cohorts.

The cancer marker is S100P.
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
Time Frame: 1 year
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.)
1 year

Collaborators and Investigators

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

Sponsor

Olympus Corporation

Collaborators

Mayo Clinic
The University of Texas Health Science Center, Houston
Kyushu University

Investigators

  • Principal Investigator: Massimo Raimondo, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMSC-PJD-1

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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