Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice

NCT02277834 | Completed

• 1 other identifier: UAB 1361
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Compare the proteomic profile between pancreatic cancer and pancreatitis

  120 months from First subject enrolled

Study Arms (3)

pancreatic adenocarcinoma

15 patients receiving Endoscopic Retrograde Cholangiopancreatography with suspected pancreatic adenocarcinoma (localized or metastatic).

chronic pancreatitis

15 patients with a history of chronic pancreatitis that are having Endoscopic Retrograde Cholangiopancreatography .

non-pancreatic, non-neoplastic disorders

15 patients undergoing an Endoscopic Retrograde Cholangiopancreatography for non-pancreatic, non-neoplastic indications.

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples will be in 3 differant cohorts; 1. Subject with biopsy-proven Pancreatic Adenocarcinoma of the pancreas 2. Subjects witha diagnosis of Pancreatitis 3. Subject with NO pancreatic abnormality

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Carlo M Contreras, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 29, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)