Status:
COMPLETED
Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
19-90 years
Brief Summary
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 stag...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Group A:
- Male or females that have suspected pancreatic adenocarcinoma, localized or metastatic.
- The pancreatic adenocarcinoma must be active, with active intra-pancreatic tumor documented within the last 3 months by CT or MRI scan.
- At least 19 years of age. (All Cohorts)
- In the Investigator's judgment, participant is mentally competent to provide informed consent to participate in the study. (All Cohorts)
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. (All Cohorts)
- Negative urine pregnancy test at screening, if applicable. (All Cohorts)
- 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:
- Male or female patients that have had chronic pancreatitis for at least 6 months.
- CT abdomen or MRI abdomen within the last 3 months demonstrating no suspicion of pancreatic adenocarcinoma.
- Group C:
- Male or female patients already scheduled to undergo upper endoscopy for non-pancreatic, non-neoplastic indications.
Exclusion
- Group A:
- The participant is medically unfit to undergo upper endoscopy.
- 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.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- The endoscopic pancreatic biopsy does not show adenocarcinoma.
- Group B:
- The participant is medically unfit to undergo upper endoscopy.
- The participant has a suspicion of pancreatic adenocarcinoma on imaging within the last 3 months.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Group C:
- The participant is medically unfit to undergo upper endoscopy.
- The participant has a history of, or current clinical suspicion of pancreatic adenocarcinoma or pancreatitis.
- The participant has a history of any type of gastrointestinal malignancy within the last 5 years.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- \-
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02277834
Start Date
August 1 2014
End Date
April 1 2016
Last Update
May 13 2016
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294