190312-NYU-DrSimeone_2021.jpg

>

CLINICAL RESEARCH STUDIES

Abstract Structure

Clinical Research Studies

S17-00651: Biomarkers in Pancreatic and Hepatobiliary Cancers 

The objective of this study is to discover and validate biomarkers in order to detect pancreatic and hepatobiliary cancers early and improve treatment outcomes by using precision medicine to understand the mechanisms of response and resistance in these cancers. The specific aims are to: 
 

  1. Develop biomarker assays that distinguish begins conditions from pancreatic cancer conditions and investigate germline variants and other risk factors for developing pancreatic cancer.   
     

  2. Establish xenografts and develop circulating tumor cell capture and sequencing techniques to study and under molecular features in pancreatic and hepatobiliary cancers and to aid in surveillance in individuals with pancreatic cancer and for those considered high risk of developing pancreatic cancer.  
     

  3. To generate proofs that show the importance of surveillance programs for pancreatic cancer and to show that the Immunovia –PanFam1 test is equal or better than current pancreatic cancer surveillance methods. 

 

We have created a biorepository of tissue, blood, and cyst fluid specimens from various pancreatic and hepatobiliary conditions including, acute and chronic pancreatitis, pancreatic cystic neoplasms and IPMNs, neuroendocrine pancreatic cancer, pancreatic ductal adenocarcinoma cancers, hepatocarcinoma, bile duct cancer and carcinoma of the pancreas. We also collect blood and saliva specimens for the biorepository from subjects whom have significant family history of pancreatic cancer and/or have genetic mutations such as BRCA 1+, BRCA 2+, ATM +, Lynch Syndrome and other mutations. All enrolled subjects study information and coded specimens are logged into our biorepository database and kept for future studies of detecting biomarkers of pancreatic and hepatobiliary cancers.  

S17-01597: Tumor Biomarkers in Pancreatic and Hepatobiliary Cancers   

The purpose of this study is to validate biomarkers for pancreatic and hepatobiliary cancers through analysis of tumor tissue in order to improve health outcomes and detect pancreatic and hepatobiliary cancers at an earlier stage. This study is a branch of the S17-00651 Biomarkers in Pancreatic and Hepatobiliary Cancers study and primarily focuses on tumor tissue and blood specimens from subjects. The specific aims are to: 

  1. Validate biomarker assays that distinguish between cancerous and benign conditions of the pancreas. Longitudinally we assess the biomarkers and tumor cells with recombinant antibody microarray platform testing  
     

  2. Validate sequencing and circulating tumor cell methods in order to isolate circulating tumor cells from blood specimens and other bodily fluid specimens for genomic analysis. Through a microfluidic labyrinth developed in collaboration with University of Michigan researchers, we can perform genomic analysis and investigate heterogeneity in individuals.
      

  3. Develop a xenograft repository to have as a resource for future collaborations and studies investigating metastasis and treatment response of pancreatic and hepatobiliary cancers.  

S19-01991: Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma  

In collaboration with Memorial Slogan Kettering Cancer Center, the goal of this multicenter pilot study is to determine the sensitivity, specificity and overall accuracy of various blood-based biomarkers for Pancreatic Ductal Adenocarcinoma Cancer (PDAC).  The specific aims are to: 

  1. Evaluate metrics for accuracy of various biomarkers in PDAC 
     

  2. In the disease cohort, correlation of longitudinal blood-based biomarkers results with standard clinical and radiographic assessment of treatment response, and for certain biomarkers concordance between results obtained from blood specimen testing and tumor tissue specimen testing. 

  

In the study there are two cohorts – a diseased cohort and a control cohort. The diseased cohort consists of untreated and potentially resectable PDAC, or/and locally advanced or metastatic pancreatic adenocarcinoma. The control cohort is an umbrella of 5 control cohorts with each cohort containing one of the following conditions: acute benign pancreatitis, chronic benign pancreatitis, cystic pancreatic lesions, IPMNs, and healthy individuals without known pancreatic disease. Blood specimens and tumor tissue specimens’ only from the disease cohort, will be collected and used for testing of presence and quantity of various biomarkers.

S20-00353: Heart Rate Variability Monitoring for the Early Detection of Pancreatic Cancer 

In collaboration with Oregon Health & Science University, The purpose of this multicenter, prospective study is to assess the performance of heart rate variability monitoring using the wearable biosensor device WHOOP! watch, in order to detect pancreatic ductal adenocarcinoma cancer (PDAC) earlier in high risk populations. The specific aims are to: 

  1. Showcase the heart rate variability in individuals with PDAC is lower in comparison to individuals whom are considered at high risk for developing PDAC 
     

  2. Assess the feasibility of long-term compliance using a wearable biosensor device. 
     

  3. Characterize timing and occurrence of PDAC among individuals whom are high risk for PDAC.  

 

Heart rate variability will be monitored longitudinally for 1 year in stage 1 enrolled subjects and a total of 5 years in stage 2 enrolled subjects. We will evaluate the decline of heart rate variability in conjunction with other clinical variables and compare these components to standard of care imaging approaches that is currently used in PDAC surveillance programs.  

S20- 00330 EA2185 Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs 

In collaboration with the ECOG-ACRIN cancer research group, the objective of this study is to compare the rates of clinical outcomes such as unresectable pancreatic cancer and/or pancreatic cancer of cancer stage higher than Stage 1A at surgery, and benign disease at surgery. The specific aims are: 

  1. To compare clinical variables such as rates of major surgical morbidity and/or mortality and pancreatic cancer incidence and all-cause mortality across the arms 
     

  2. To compare healthcare resource related aspects such as institutional costs, utilization of imaging, invasive testing and procedures, patient out of pocket costs and diagnostics tests across the study arms. Also compare patient reports of situational anxiety and financial distress. 
     

  3. To evaluate and compare predictive performance of known and discovered biomarkers for cancer.

S20-00236 PRECEDE Consortium 

The purpose of this prospective cohort study is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multi-site cohort of individuals with family history of PDAC and/or individuals with pathogenic germline variants (PGVs) in genes linked to PDAC. We want to create a shared resource to drive research in early detection and prevention of PDAC. The specific aims are to: 
 

  1.  Standardize collection of subject information including demographics, clinical and imaging data, and the collection of biospecimens for large high risk familial PDAC cohorts in other centers worldwide. Also enhance and test performance of communication tools for patients and healthcare providers 
     

  2. Establish evidence-based practice standards for genetic testing and generate proof for the importance of surveillance in individuals with family history of PDAC and/or individuals whom have a genetic mutation linked to PDAC risk.  
     

  3. Develop comprehensive risk models to estimate PDAC risk and study modifiers of various risk factors to evaluate penetrance of disease and be able to quantify cancer risk. Also, develop and validate biomarker assays that distinguish individuals with PDAC from benign pancreas conditions. 

nyu-langone-pancreatic-cancer-research-l

© 2020 by Simeone Pancreatic Cancer Research Lab, Inc  |  Site Design by Market Street