Pancreatic Juice Diagnosis From Duodenum

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Olympus Medical Systems Corporation
Sponsor:
Collaborators:
Mayo Clinic
Kyushu University
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Olympus Medical Systems Corporation
ClinicalTrials.gov Identifier:
NCT01699698
First received: September 24, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.


Condition Intervention
Pancreatic Adenocarcinoma
Other: Tumor markers

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Pancreatic Juice Diagnosis From Duodenum

Resource links provided by NLM:


Further study details as provided by Olympus Medical Systems Corporation:

Primary Outcome Measures:
  • The concentration of the pancreatic cancer markers of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort [ Time Frame: 1year ] [ Designated as safety issue: No ]
    To clarify that there is the statistically-significant difference between two cohorts


Secondary Outcome Measures:
  • The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699698

Contacts
Contact: Massimo Raimondo, MD (904)953-6982 raimondo.massimo@mayo.edu

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States
Contact: Massimo Raimondo, M.D.         
Principal Investigator: Massimo Raimondo, M.D.         
Japan
Kyushu University Recruiting
Fukuoka-shi, Fukuoka-ken, Japan
Sponsors and Collaborators
Olympus Medical Systems Corporation
Mayo Clinic
Kyushu University
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Massimo Raimondo, M.D. Mayo Clinic
  More Information

Publications:
Responsible Party: Olympus Medical Systems Corporation
ClinicalTrials.gov Identifier: NCT01699698     History of Changes
Other Study ID Numbers: OMSC-PJD-1
Study First Received: September 24, 2012
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Olympus Medical Systems Corporation:
Pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014