Pancreatic Juice Diagnosis From Duodenum
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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 |
- 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
- 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 2013 |
| Estimated Primary Completion Date: | September 2013 (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 |
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| Contact: Massimo Raimondo, MD | (904)953-6982 | raimondo.massimo@mayo.edu |
| 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 | |
| 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: | November 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Olympus Medical Systems Corporation:
|
Pancreatic adenocarcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 22, 2013