Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02277834
Eligibility Criteria:
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.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
90 Years
Study:
NCT02277834
Study Brief:
Protocol Section:
NCT02277834