Clinical trial NCT02277834: Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice
Official title: Characterizing the Pancreatic Adenocarcinoma Proteome From Pancreatic Juice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A: Participants with a confirmed diagnosis of a pancreatic adenocarcinoma will be enrolled in this study. Potential participants will be identified from the Surgical Oncology and Gastroenterology outpatient settings.

Group B: Participants with a confirmed diagnosis of chronic pancreatitis will be enrolled in this study. Participants will be derived from the Gastroenterology and Gastrointestinal Surgery outpatient setting.

Group C: Participants undergoing endoscopy for non-pancreatic, non-neoplastic indications. The typical patient population we anticipate recruiting to this group with be those with non-malignant, non-pancreatitis biliary calculous disease. Participants will be derived from the Gastroenterology outpatient setting.

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 stage.

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 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.

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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Primary outcomes:
measure: Compare the proteomic signature of pancreatic adenocarcinoma , pancreatic cancer and control participants to the disease process
timeFrame: 120 months from First subject enrolled
Secondary outcomes:
measure: Compare the proteomic profile between pancreatic cancer and pancreatitis
timeFrame: 120 months from First subject enrolled
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Carlo M Contreras, MD
role: PRINCIPAL_INVESTIGATOR
References: