Project Survival-Prospective Biomarker Discovery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02781012|
Recruitment Status : Unknown
Verified April 2019 by Pancreatic Cancer Research Team.
Recruitment status was: Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : April 16, 2019
|Condition or disease|
|Pancreatic Neoplasms Pancreatic Cancer Pancreatitis Pancreatic Adenocarcinoma Metastatic Pancreatic Cancer|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||436 participants|
|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|
Healthy volunteers without any known pancreatic disease
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.
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.
Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapy/therapies.
- 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
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
|United States, Arizona|
|Banner Health - MD Anderson Cancer Center|
|Gilbert, Arizona, United States, 85234|
|Mayo Clinic - Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Mercy Health - St. Mary's|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|Virginia Piper Cancer Institute - Allina Health|
|Minneapolis, Minnesota, United States, 55407|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||A. James Moser, MD||Beth Israel Deaconess Medical Center, Harvard University|
|Principal Investigator:||Tomislav Dragovich, MD||Banner Health - MD Anderson Cancer Center|