Trial Outcomes & Findings for Pancreatic Juice Diagnosis From Duodenum (NCT NCT01699698)
NCT ID: NCT01699698
Last Updated: 2015-09-21
Results Overview
We hypothesized that there is a statistically-significant difference between two cohorts. The cancer marker is S100P.
COMPLETED
NA
105 participants
1year
2015-09-21
Participant Flow
Participant milestones
| Measure |
Test Subject
UICC StageII pancreatic ductal adenocarcinoma cohort
|
Control
Normal cohort
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
61
|
|
Overall Study
COMPLETED
|
42
|
56
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pancreatic Juice Diagnosis From Duodenum
Baseline characteristics by cohort
| Measure |
Test Subject
n=42 Participants
UICC Stage II pancreatic ductal adenocarcinoma cohort
|
Control
n=56 Participants
Normal cohort
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
60 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
28 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
22 participants
n=5 Participants
|
28 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1yearWe hypothesized that there is a statistically-significant difference between two cohorts. The cancer marker is S100P.
Outcome measures
| Measure |
Test Subject
n=42 Participants
UICC Stage II pancreatic ductal adenocarcinoma cohort
|
Control
n=56 Participants
Normal cohort
|
|---|---|---|
|
The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
|
99097 pg/ml
Interval 7386.0 to 1985933.0
|
34095 pg/ml
Interval 611.0 to 497630.0
|
SECONDARY outcome
Timeframe: 1 yearBased 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.)
Outcome measures
| Measure |
Test Subject
n=42 Participants
UICC Stage II pancreatic ductal adenocarcinoma cohort
|
Control
n=56 Participants
Normal cohort
|
|---|---|---|
|
The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
|
31 participants
|
17 participants
|
Adverse Events
Test Subject
Normal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can ask PI to consider that PI delete Sponsor's confidential information from any publication or extend the publication for a certain time to seek patent protection, provided, however that, PI can publish or registry any other information in accordance with FDAAA.
- Publication restrictions are in place
Restriction type: OTHER