Pancreatic Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 90 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the proteomic signature of pancreatic adenocarcinoma , pancreatic cancer and control participants to the disease process | Characterization of the proteomic signature of patients with pancreatic adenocarcinoma, pancreatic cancer, and control participants. This will be accomplished by classifying a group or set of similar proteomic profiles(once we(once we have developed from the samples obtained a list of known proteomic profiles taht are found in all pancreatic adenocarcinoma subjects) that are specific to the disease process,of pancreatic adenocarcinoma. | 120 months from First subject enrolled | No |
Secondary | Compare the proteomic profile between pancreatic cancer and pancreatitis | Using the discovered pancreatic adenocarcinoma proteomic profile we will differentiate a documentable difference from pancreatic cancer and pancreatitis | 120 months from First subject enrolled | No |
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