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Project Survival-Prospective Biomarker Discovery

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ClinicalTrials.gov Identifier: NCT02781012
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Berg, LLC
Information provided by (Responsible Party):
Pancreatic Cancer Research Team

Brief Summary:
This sample-collection study is open to participants in several categories: healthy volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed with pancreatitis or any stage of pancreatic cancer. All participants will submit urine, saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue samples if biopsy/ies or surgery is part of the care being provided by their doctor. In partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early detection of pancreatic cancer, to determine prognosis of patients, and to find the most appropriate treatments for patients.

Condition or disease
Pancreatic Neoplasms Pancreatic Cancer Pancreatitis Pancreatic Adenocarcinoma Metastatic Pancreatic Cancer

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Project Survival-Prospective Biomarker Discovery to Transform Diagnosis and Treatment for Patients With Pancreatic Diseases and Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy
Healthy volunteers without any known pancreatic disease
Healthy At-Risk
Healthy volunteers with no known benign or malignant pancreatic disease, AND with one first-degree relative with pancreatic cancer, OR two second-degree relatives with pancreatic cancer. These subjects also include those who have undergone surgery for suspected pancreatic cancer, and who are found to have a non-pancreatic cancer pathology upon final local site or central pathology review.
Pancreatitis
Subjects diagnosed with acute or chronic pancreatitis
Early Stage/Borderline/Locally Advanced
Subjects diagnosed with early stage pancreatic cancer who undergo surgery as standard of care therapy with or without preoperative (neoadjuvant) chemotherapy and/or radiation therapy; subjects diagnosed with borderline pancreatic cancer, or subjects diagnosed with locally advanced pancreatic cancer.
Metastatic
Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapy/therapies.



Primary Outcome Measures :
  1. Berg's Interrogative Biology® Platform [ Time Frame: Sample analysis will occur throughout enrollment period (5 years), and outcomes will be assessed at end of enrollment period. ]
    Tissue and fluid samples will be analyzed using Berg's Interrogative Biology® Platform, which uses biomolecular analyses paired with artificial intelligence to identify and validate biomarkers that can be used for early detection of pancreatic diseases, including pancreatic cancer, and to determine the prognosis of patients, and best therapeutic treatment for specific patients.


Biospecimen Retention:   Samples With DNA
Blood (serum, plasma, buffy coat), saliva, urine, and pancreatic tissue designated as surgical waste by site's treating pathologist.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study will enroll participants in several categories:

  • Healthy Volunteers,
  • Healthy At-Risk Volunteers (whose immediate or extended family member(s) were diagnosed with Pancreatic Cancer),
  • Patients with a suspected malignant tumor in pancreas who require surgery,
  • Pancreatitis Patients (both Acute and Chronic), and
  • Patients with all stages of Pancreatic Cancer.
Criteria

Inclusion Criteria:

  1. Subject is over 18 years of age and has been evaluated at a participating Pancreatic Cancer Research Team (PCRT) study site, AND
  2. Subject has been recently diagnosed with pancreatic cancer (any stage) OR
  3. Subject has been recently (within 12 months) diagnosed with acute or chronic pancreatitis OR
  4. A healthy individual, with no known pancreatic disease (cancerous or otherwise), AND with one first-degree relative with pancreatic cancer, OR two second-degree relatives with pancreatic cancer OR one who has undergone surgery for suspected pancreatic cancer, and who is found to have a non-pancreatic cancer pathology upon final local site or central pathology review, OR
  5. A healthy individual with no known benign or malignant pancreatic disease, and no family history of pancreatic cancer.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Subject is < 18 years old.
  • Subject has been diagnosed with a primary cancer other than pancreas in the past 5 years, and is currently receiving treatment for this cancer.
  • Subject is a pregnant or lactating female;
  • Subject is not willing or is unable to give informed consent to this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781012


Contacts
Contact: Amy Stoll-D'Astice, MS, CCRP 206-816-4239 amys@crab.org
Contact: Sarah J. Basse, BA 206-839-1739 sarahb@crab.org

Locations
United States, Arizona
Banner Health - MD Anderson Cancer Center Active, not recruiting
Gilbert, Arizona, United States, 85234
Mayo Clinic - Arizona Active, not recruiting
Phoenix, Arizona, United States, 85054
United States, Massachusetts
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Mercy Health - St. Mary's Active, not recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Virginia Piper Cancer Institute - Allina Health Active, not recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jesse Huffman    314-747-6268    jessehuffman@wustl.edu   
Principal Investigator: Andrea Wang-Gillam, PhD, MD         
Sponsors and Collaborators
Pancreatic Cancer Research Team
Berg, LLC
Investigators
Principal Investigator: A. James Moser, MD Beth Israel Deaconess Medical Center, Harvard University
Principal Investigator: Tomislav Dragovich, MD Banner Health - MD Anderson Cancer Center

Additional Information:
Responsible Party: Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT02781012     History of Changes
Other Study ID Numbers: PCRT 15-001
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pancreatic Cancer Research Team:
Pancreatic Disease
Pancreas
Borderline Resectable
Pancreatic Cancer
Pancreatitis
Family history of pancreatic cancer
Healthy
Healthy at risk

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Pancreatitis
Pancreatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases