Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - 90
Updated:4/21/2016
Start Date:August 2014
End Date:March 2016
Contact:Joseph H Richardson, RN/CCRC
Email:jhrichardson@uabmc.edu
Phone:(205)975-0450

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Characterizing the Pancreatic Adenocarcinoma Proteome From Pancreatic Juice

Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are
collecting and studying the fluid produced by the pancreas as a way to detect pancreatic
cancer at an earlier stage.

Pancreatic cancer is very difficult to detect and treat, and patients with this cancer
generally live fewer years than patients with other types of cancer. Part of the reason why
pancreatic cancer is so hard to treat is because it is usually discovered when it is too
advanced to be able to treat. The goal of this protocol is to find a way to detect
pancreatic cancer earlier, when it is still treatable in order to improve the survival of
patients.

The pancreas is a gland which produces digestive juices that mix with food in the
intestines. Normal patients as well as patients with pancreatic cancer produce these juices.
Other researchers have collected this fluid from very small numbers of patients and their
results suggest that pancreatic fluid can be used to detect pancreatic cancer. One of the
major issues with these results is that pancreatic fluid from only a very few number of
patients has been collected and analyzed. In order to find out whether the pancreatic fluid
can be used as a standard test for pancreatic cancer, the fluid from a greater number of
patients needs to be analyzed. Also, of all the different chemicals in the pancreatic fluid,
in this study we will try to figure out what the most important chemicals are in diagnosing
pancreatic cancer.

Inclusion Criteria:Group A:

1. Male or females that have suspected pancreatic adenocarcinoma, localized or
metastatic.

2. The pancreatic adenocarcinoma must be active, with active intra-pancreatic tumor
documented within the last 3 months by CT or MRI scan.

3. At least 19 years of age. (All Cohorts)

4. In the Investigator's judgment, participant is mentally competent to provide informed
consent to participate in the study. (All Cohorts)

5. Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. (All Cohorts)

6. Negative urine pregnancy test at screening, if applicable. (All Cohorts)

7. The patient must already have a completed, active consent for either endoscopic
ultrasound(EUS) and/or endoscopic retrograde cholangiopancreatography (ERCP) at
University of Alabama at Birmingham(UAB). (All Cohorts)

Group B:

1. Male or female patients that have had chronic pancreatitis for at least 6 months.

2. CT abdomen or MRI abdomen within the last 3 months demonstrating no suspicion of
pancreatic adenocarcinoma.

Group C:

1.Male or female patients already scheduled to undergo upper endoscopy for non-pancreatic,
non-neoplastic indications.

Exclusion Criteria:Group A:

1. The participant is medically unfit to undergo upper endoscopy.

2. No cancer-directed therapy administered within the last 3 months. This includes any
of the following: surgical resection, chemotherapy, radiation therapy, immunologic or
biologic therapy.

3. Participants with a known allergy to secretin.

4. Participants who are pregnant or lactating, or intending to become pregnant during
the study.

5. Participants of childbearing potential who refuse a pregnancy test.

6. Participants who, in the opinion of the Investigator, should not be included in the
study for any reason, including inability to follow study procedures.

7. Participants who have participated in an investigational surgical, drug, or device
study within the past 30 days.

8. Participants who currently have a biliary stent in place.

9. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.

10. The endoscopic pancreatic biopsy does not show adenocarcinoma.

Group B:

1. The participant is medically unfit to undergo upper endoscopy.

2. The participant has a suspicion of pancreatic adenocarcinoma on imaging within the
last 3 months.

3. Participants with a known allergy to secretin.

4. Participants who are pregnant or lactating, or intending to become pregnant during
the study.

5. Participants of childbearing potential who refuse a pregnancy test.

6. Participants who, in the opinion of the Investigator, should not be included in the
study for any reason, including inability to follow study procedures.

7. Participants who have participated in an investigational surgical, drug, or device
study within the past 30 days.

8. Participants who currently have a biliary stent in place.

9. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.

Group C:

1. The participant is medically unfit to undergo upper endoscopy.

2. The participant has a history of, or current clinical suspicion of pancreatic
adenocarcinoma or pancreatitis.

3. The participant has a history of any type of gastrointestinal malignancy within the
last 5 years.

4. Participants with a known allergy to secretin.

5. Participants who are pregnant or lactating, or intending to become pregnant during
the study.

6. Participants of childbearing potential who refuse a pregnancy test.

7. Participants who, in the opinion of the Investigator, should not be included in the
study for any reason, including inability to follow study procedures.

8. Participants who have participated in an investigational surgical, drug, or device
study within the past 30 days.

9. Participants who currently have a biliary stent in place.

10. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Carlo M Contreras, MD
Phone: 205-975-9729
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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mi
from
Birmingham, AL
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