Project Survival-Prospective Biomarker Discovery

NCT02781012 | Unknown

• 1 other identifier: PCRT 15-001
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer; Pancreatitis; Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer

Keywords

Pancreatic Disease; Pancreas; Borderline Resectable; Pancreatic Cancer; Pancreatitis; Family history of pancreatic cancer; Healthy; Healthy at risk

Outcome Measures

Primary Outcomes (1)

• Berg's Interrogative Biology® Platform

  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.

  Sample analysis will occur throughout enrollment period (5 years), and outcomes will be assessed at end of enrollment period.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is over 18 years of age and has been evaluated at a participating Pancreatic Cancer Research Team (PCRT) study site, AND
• Subject has been recently diagnosed with pancreatic cancer (any stage) OR
• Subject has been recently (within 12 months) diagnosed with acute or chronic pancreatitis OR
• 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
• A healthy individual with no known benign or malignant pancreatic disease, and no family history of pancreatic cancer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pancreatic Cancer Research Team: lead
• BPGbio: collaborator

Study Sites (6)

Banner Health - MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic - Arizona

Phoenix, Arizona, 85054, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mercy Health - St. Mary's

Grand Rapids, Michigan, 49503, United States

Location

Virginia Piper Cancer Institute - Allina Health

Minneapolis, Minnesota, 55407, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Project Survival Patient Information Webpage

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis; Pancreatic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• A. James Moser, MD

  Beth Israel Deaconess Medical Center, Harvard University

  PRINCIPAL INVESTIGATOR

• Tomislav Dragovich, MD

  Banner Health - MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 24, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)