Project Survival-Prospective Biomarker Discovery

Learn more about:
Related Clinical Trial
Arginine-stimulated Prediction of Early Outcome After Islet Transplantation Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China. A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors Establishment and Verification of Pancreatic Volume Formula Based on Imaging Efficacy of Energy Therapy in the Management of Chronic Pain Medical Condition in Children and Adolescents. Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP Comparison of Efficacy of Basket and Balloon in the Removal of Pancreatic Duct Stones in Chronic Pancreatitis Under ERCP Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis. Endotherapy for Painless Chronic Pancreatitis Intestinal Microbiota Composition in Patients With Chronic Pancreatitis and Pancreatic Exocrine Insufficiency Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis Prospective Registry Of Therapeutic EndoscopiC ulTrasound Intermittent Fasting for Pancreatitis Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies, the PROCEED Study Relationship of CP and AP Personalized Education and Pain Response in Chronic Pancreatitis A Prospective Cohort Study of Large Pancreatic Radiolucent Stone Risk Factors for Post-ESWL and Post-ERCP Pancreatitis Intraductal Liposomal Bupivacaine for Chronic Pancreatitis An Observational Study on the Natural Course of Chronic Pancreatitis Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study Malnutrition in Chronic Pancreatitis, Trans-sectoral Study Project Survival-Prospective Biomarker Discovery Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study Volatiles in Breath and Headspace Analysis – Diagnostic Markers Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis Cancer in Patients With Gabapentin (GPRD) A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma Rectal Indomethacin to Prevent Post ESWL-pancreatitis T-EUS for Gastrointestinal Disorders: A Multicenter Registry Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool Contrast EUS of the Pancreas Idiopathic Recurrent Acute Pancreatitis (IRAP) Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study) Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis Endoscopic Ultrasound (EUS) Processor Comparison The North American Pancreatitis Study A Prospective Observational Study of TPIAT Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation Economisation of Whipple Resection Using an Ultrasonic Dissection Device Biospecimens for Identification of Diseases of the Pancreas. Diagnosis of Bile Duct Strictures Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD) Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT Prospective Study of Celiac Block Injection: 1 vs. 2 Online Health Assessment to Support Comprehensive Care Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer Mesenchymal Stem Cell and Islet Co-transplantation Analysis of Graft Function Following Autologous Islet Transplantation Carbon Monoxide-Saturated Medium for Islet Isolation Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) in Focal Pancreatic Masses Endoscopic Ultrasound Elastography in Pancreatic Masses Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis A Prospective Study of Natural History of Pancreatitis Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain ESWL Versus ESWL and Endoscopic Treatment SpHincterotomy for Acute Recurrent Pancreatitis A Prospective Study of EUS Guided Celiac Block A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 Examining Macrophage Influx and Vascularization in Chronic Pancreatitis Enzyme Suppletion in Exocrine Pancreatic Dysfunction ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis A Phase IIa Study With Escalating Dose of MS1819-SD Decrease of Recurrent Pancreatitis Celiac Plexus Block for Chronic Pancreatitis RCT Pancreatic Perfusion Using Secretin and MRI Viokase 16, Viokase16 Plus Nexium and Nexium Alone Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis Endoscopic Stenting for Chronic Abdominal Pain WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) The Incretin Effect in Patients With Chronic Pancreatitis Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis Fibro-inflammatory Progression From Acute to Chronic Pancreatitis CT Pancreas Perfusion CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption The Natural History of Chronic Pancreatitis BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency Is There an Association Between Chronic Pancreatitis and Pulmonary Function Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing Pain and Chronic Pancreatitis – Clinical End Experimental Studies A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis Trial of Indomethacin in Chronic Pancreatitis The Diagnosis of Chronic Pancreatitis Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality Effect of Acetyl-L-carnitine on Chronic Pancreatitis Establishing Standards for Normal Pancreatic EUS The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis Secretin Infusion for Pain Due to Chronic Pancreatitis Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Elastography in the Diagnosis of Chronic Pancreatitis The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies Endoscopic Versus Surgical Treatment of Chronic Pancreatitis Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis Novel Breath Test to Detect Early Stage Chronic Pancreatitis Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions Dietary Soy Isoflavones In Chronic Pancreatitis Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis Nerve Growth Factor in Chronic Pancreatitis Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT) Role of Antioxidants Supplementation in Chronic Pancreatitis Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis Bone Disease in Chronic Pancreatitis: A Complex Phenomenon Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria

Brief Title

Project Survival-Prospective Biomarker Discovery

Official Title

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

        -  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.

Study Type

Observational [Patient Registry]

Primary Outcome

Berg's Interrogative Biology® Platform


Pancreatic Neoplasms

Study Arms / Comparison Groups

Description:  Healthy volunteers without any known pancreatic disease


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

March 2016

Completion Date

February 2022

Primary Completion Date

February 2022

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

          -  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.




18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


A. James Moser, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

PCRT 15-001

Responsible Party


Study Sponsor

Pancreatic Cancer Research Team


 Berg, LLC

Study Sponsor

A. James Moser, MD, Principal Investigator, Beth Israel Deaconess Medical Center, Harvard University

Verification Date

April 2019