Pancreatic Juice Diagnosis From Duodenum

• Sponsor: Olympus Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01699698
• Collaborator: Mayo Clinic (Other), Kyushu University (Other), The University of Texas Health Science Center, Houston (Other)
• Enrollment: 105
• Locations: 2
• Arm: 1
• Patients Per Site: 52.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma	Other: Tumor markers	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Pancreatic Juice Diagnosis From Duodenum
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jul 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Jacksonville	Jacksonville	Florida	United States
2	Kyushu University	Fukuoka-shi	Fukuoka-ken	Japan

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Pungpapong S, Noh KW, Woodward TA, Wallace MB, Al-Haddad M, Raimondo M. Endoscopic ultrasound and IL-8 in pancreatic juice to diagnose chronic pancreatitis. Pancreatology. 2007;7(5-6):491-6. Epub 2007 Oct 1.

• Responsible Party: Olympus Corporation
• ClinicalTrials.gov Identifier: NCT01699698
• Other Study ID Numbers: OMSC-PJD-1
• First Posted: Oct 4, 2012
• Last Update Posted: Sep 21, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Olympus Corporation: Pancreatic adenocarcinoma
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

Participant Flow

Arm/Group Title	Test Subject	Control
Arm/Group Description	UICC StageII pancreatic ductal adenocarcinoma cohort	Normal cohort
Period Title: Overall Study
STARTED	44	61
COMPLETED	42	56
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	Test Subject	Control	Total
Arm/Group Description	UICC Stage II pancreatic ductal adenocarcinoma cohort	Normal cohort	Total of all reporting groups
Overall Participants	42	56	98
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 31%	36 64.3%	49 50%
>=65 years	29 69%	20 35.7%	49 50%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	70	60	64
Sex: Female, Male (Count of Participants)
Female	13 31%	36 64.3%	49 50%
Male	29 69%	20 35.7%	49 50%
Region of Enrollment (participants) [Number]
United States	20 47.6%	28 50%	48 49%
Japan	22 52.4%	28 50%	50 51%

Outcome Measures

1. Primary Outcome

Title	The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort
Description	We hypothesized that there is a statistically-significant difference between two cohorts. The cancer marker is S100P.
Time Frame	1year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Subject	Control
Arm/Group Description	UICC Stage II pancreatic ductal adenocarcinoma cohort	Normal cohort
Measure Participants	42	56
Median (Full Range) [pg/ml]	99097	34095

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Subject, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Subject	Control
Arm/Group Description	UICC StageII pancreatic ductal adenocarcinoma cohort	Normal cohort
Measure Participants	42	56
Number [participants]	31 73.8%	17 30.4%

Adverse Events

Arm/Group Title	Test Subject		Normal
Arm/Group Description	UICC StageII pancreatic ductal adenocarcinoma cohort		Normal cohort
All Cause Mortality
	Test Subject		Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Test Subject		Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Test Subject		Normal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.