Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatitis

Pancreatic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

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

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.

A. James Moser, MD

Tomislav Dragovich, MD

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.

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.

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

Project Survival-Prospective Biomarker Discovery

Project Survival-Prospective Biomarker Discovery to Transform Diagnosis and Treatment for Patients With Pancreatic Diseases and Cancer

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.

Berg, LLC

Pancreatic Cancer Research Team

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Secretin

Hormones

Hormone Antagonists

Subjects will each undergo a Secretin-Enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and a Secretin-Enhanced Endoscopic Ultrasound (S-EUS) evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Synthetic Human Secretin

Secretin-Enhanced Magnetic Resonance Cholangiopancreatography

Secretin-Enhanced Endoscopic Ultrasound

Elizabeth Hecht, MD

The aim of our study is to evaluate the utility of Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in detecting carcinoma and precancerous lesions in patients with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that S-MRCP is superior to traditional computed tomography (CT) or magnetic resonance imaging (MRI) in detecting early pancreatic neoplasms, and approaches the accuracy of endoscopic ultrasound (EUS).

Pancreatic cancer remains the fourth leading cause of cancer-related death in the United States, largely due to the lack of accurate and cost-effective screening methods. Initial screening efforts should be directed at patients with known increased genetic risk for pancreatic adenocarcinoma. About 10-20% of pancreatic cancers are considered familial or syndromic. Since pancreatic adenocarcinoma is known to progress from preneoplastic lesions, termed pancreatic intraepithelial neoplasia (PanIN), it may eventually be possible to identify and cure patients by detecting preneoplastic lesions. Traditional radiological methods lack the resolution to detect early lesions. The sensitivity and specificity of endoscopic retrograde cholangiopancreatography (ERCP) (92%,96%) and EUS (93-98%)are better, but these procedures are invasive and limited in availability. Magnetic resonance cholangiopancreatography (MRCP) has emerged as a widely-accepted alternative with comparable sensitivity to ERCP. Magnetic Resonance Cholangiopancreatography (MRCP) has been further augmented by secretin stimulation, which improves visualization of the pancreatic duct as well as side branches. We will recruit 25 patients for a prospective pilot study examining S-MRCP as a screening technique in high-risk individuals. All recruited patients will undergo S-MRCP in conjunction with magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), as well as secretin-enhanced EUS (S-EUS). Those patients with abnormalities on S-MRCP or S-EUS will undergo ERCP. If ERCP also shows abnormalities, these patients will be recommended total or subtotal pancreatectomy. The primary outcome that we will be studying will be concordance of S-MRCP and EUS. Secondarily, we will be measuring positive predictive value of S-MRCP, in comparison with EUS and ERCP in identifying neoplasm in those patients who undergo surgical resection during this study.

Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients

Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study

The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.

Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.

Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

Elizabeth Hecht

Associate Professor of Clinical Radiology

Single arm (open label).

Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Single arm (open label).

Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Project Survival-Prospective Biomarker Discovery	NCT02781012	Pancreatic Neop... Pancreatic Canc... Pancreatitis Pancreatic Aden... Metastatic Panc...		18 Years -	Pancreatic Cancer Research Team
Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients	NCT01094561	Pancreatic Canc...	Synthetic Human... Secretin-Enhanc... Secretin-Enhanc...	18 Years - 65 Years	Columbia University

Spots Global Cancer Trial Database for family history of pancreatic cancer