Pancreatic Adenocarcinoma
Conditions
Keywords
Pancreatic adenocarcinoma
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.
Interventions
OTHERTumor markers
Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.
Sponsors
Mayo Clinic
Kyushu University
The University of Texas Health Science Center, Houston
Olympus Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort | 1year | We hypothesized that there is a statistically-significant difference between two cohorts. The cancer marker is S100P. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants. | 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.) |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subject UICC Stage II pancreatic ductal adenocarcinoma cohort | 42 |
| Control Normal cohort | 56 |
| Total | 98 |
Baseline characteristics
| Characteristic | Test Subject | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 20 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 36 Participants | 49 Participants |
| Age, Continuous | 70 years | 60 years | 64 years |
| Region of Enrollment Japan | 22 participants | 28 participants | 50 participants |
| Region of Enrollment United States | 20 participants | 28 participants | 48 participants |
| Sex: Female, Male Female | 13 Participants | 36 Participants | 49 Participants |
| Sex: Female, Male Male | 29 Participants | 20 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 56 |
| serious Total, serious adverse events | 0 / 42 | 0 / 56 |
Outcome results
Primary
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.
Time frame: 1year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Subject | The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort | 99097 pg/ml |
| Control | The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort | 34095 pg/ml |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
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.)
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subject | The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants. | 31 participants |
| Control | The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants. | 17 participants |