Clinical trial NCT02781012: Project Survival-Prospective Biomarker Discovery
Official title: Project Survival-Prospective Biomarker Discovery to Transform Diagnosis and Treatment for Patients With Pancreatic Diseases and Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Pancreatic Cancer Research Team
Sponsor class: OTHER
Collaborators: name: BPGbio
First posted: 2016-05-24
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The Primary Objective of this study is to identify and validate biomarkers that can be used for early detection and selection of personalized treatment of pancreatic diseases, including adenocarcinoma and pancreatitis. A maximum of 600 subjects will be enrolled in this study, including healthy volunteers, subjects with acute and chronic pancreatitis, family members at risk for pancreatic cancer (as defined below), and subjects with all stages of pancreatic adenocarcinoma who will contribute samples annotated with longitudinal clinical data. Biomarkers will be investigated for potential as Theranostic, Prognostic, Diagnostic and Therapeutic indicators among subjects with pancreatitis and pancreatic cancer.

Examples of eligible participants include:

* Healthy volunteers without any known pancreatic disease (50 subjects)
* 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. (100 subjects).
* Subjects diagnosed acute or chronic pancreatitis (50 subjects).
* 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 (200 subjects). Enrollment of treatment naïve subjects with early stage pancreatic cancer is preferred.
* Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of care therapies, such as gemcitabine/Abraxane or FOLFIRINOX as front-line treatment with or without associated radiation treatment (200 subjects). Enrollment of treatment naïve subjects with metastatic pancreatic cancer is preferred.

Consented and enrolled subjects will be asked to participate in this study in the following ways:

* Subjects will be asked to contribute blood (serum, buffy coat, and plasma), urine, and saliva after enrollment, and at clinically-significant timepoints throughout their treatment as indicated by their disease state.
* Subjects undergoing surgery for pancreatic disease will also be asked to donate diseased and adjacent non-diseased pancreatic tissue, defined as "excess" tissue from diagnostic or therapeutic biopsy or surgical procedures that is no longer required for standard of care purposes.
* Examples of "excess" tissue after a standard of care surgical procedures include any/all biopsies or resections performed and may include non-diseased pancreatic tissue and pancreatic tumor tissue.
* These collection procedures will not alter or prolong the conduct of standard of care surgical procedures.

Subsequent liquid non-tissue samples will be collected from all subjects at the following clinically-relevant time points related to standard of care treatment for pancreatic disease:

* Before, at the time of, and/or after surgery to remove a pancreatic tumor or inflammatory mass;
* before and after chemotherapy and/or radiation for cancer;
* upon local, regional, or distant progression of cancer;
* resolution of the disease process.

Blood (serum, plasma, and buffy coat), urine and saliva will not be collected more than six (6) times in a 12 month period per subject.

Samples will be collected until the subject withdraws or the study has completed enrollment.

Eligibility 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.

Primary outcomes:
measure: Berg's Interrogative Biology® Platform
timeFrame: Sample analysis will occur throughout enrollment period (5 years), and outcomes will be assessed at end of enrollment period.
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Health - MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Mercy Health - St. Mary's
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute - Allina Health
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Harvard University
name: A. James Moser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Banner Health - MD Anderson Cancer Center
name: Tomislav Dragovich, MD
role: PRINCIPAL_INVESTIGATOR
References: