Pancreatic Cancer Early Detection for People at High Risk

About the Study

The study will collect clinical information, family history, and samples (blood, saliva or cheek swab) from people and families at risk for pancreatic cancer. Collecting this information and samples will create a resource to drive research necessary for early detection and prevention of pancreatic ductal adenocarcinoma (PDAC).

What the Study Involves:

Study participation may include:

• Providing a blood sample (about 4 tablespoons) at each clinic visit throughout the course of the study.
• Providing a DNA and RNA sample that will be extracted from blood, saliva, or cheek swab
• Providing medical and family history information to be included in the study database
• Providing permission to access your medical records, retrieve results from routine clinical care, such as genetic testing, imaging studies (eg MRI/MRCP, endoscopic ultrasound, CT abdomen)
• A baseline clinical visit and up to 2 visits per year, depending on the frequency of your clinical care pancreas cancer screening
• Providing a blood sample and medical records at any event driven clinical follow up of abnormal findings with imaging and lab studies
• If you are diagnosed with pancreatic cancer, you will be asked to donate extra tissue at the time of clinical biopsies or surgeries

The study will enroll people from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE study:

Group 1:

Individuals without personal diagnosis of PDAC meeting any of the following criteria:

• 2 or more relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age: 50 or older or 10 or more years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with pancreatic cancer; age: 50 or older or 10 years younger than earliest pancreatic cancer  in family
• Inherited mutation in BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest pancreatic cancer in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with inherited mutation in CDKN2A; age: 40 or older
• Peutz-Jegher syndrome with an inherited STK11 mutation; age: 35 or older
• Hereditary pancreatitis with and inherited PRSS1 mutation and history of pancreatitis; age: 40 or older

Group 2

Individuals without a personal diagnosis  of PDAC meeting any of the following criteria:

• ATM, BRCA1, BRCA2, or PALB2 inherited mutation regardless of family history, age: 50 or older
• 2+ relatives with pancreatic cancer on the same side of family, any degree of relation, not meeting other criteria above; age: 50 or older or 10 years younger than earliest pancreatic cancer in family
• 1 first degree relative with pancreatic cancer at or younger than age 45; age: up to 10 years younger than PDAC diagnosis in family member

Group 3

• Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)

Group 4

• Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Group 5

• Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.

Group 6

Individuals with a personal history of PDAC meeting any of the following criteria:

• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45

Cyst Group

• Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)

Please Note: The study does not cover the cost of screening and additional office visits needed to complete the requirement for the study. 

Study Locations

California

• Burbank
  Providence Health and Services
  Contact: Miles Picus  [email protected]
  Lead researcher: Ora Gordan
• Duarte
  City of Hope
  Contact: Diamond Ward [email protected]   
  Lead researcher: James Lin         
  Lead researcher: Greg Idos         
• La Jolla
  UC San Diego Moores Cancer Center
  Contact: Shirley Sarno [email protected]   
  Lead researcher: Andy Lowy         
  Lead researcher: Joy Liau         
• Los Angeles
  Cedars-Sinai Medical Center
  Contact: Liliana Bancila 310-423-3872 [email protected]   
  Lead researcher: Srinivas Gaddam   
• Los Angeles
  UCLA Health
  Contact: Aletta Deranterisassian [email protected]     
  Lead researcher: Timthy Donahue
• Sacramento
  UC Davis
  Contact: Anthony Martinez [email protected]
  Lead researcher: Edward Kim
• San Francisco
  University of California, San Francisco (UCSF)
  Contact: Kurt Giles [email protected]

Connecticut

• New Haven
  Yale University
  Contact: Scott Merenda [email protected]   
  Lead researcher: James Farrell         

Florida

• Jacksonville
  Mayo Clinic, Jacksonville
  Contact: Guillermo Pradieu [email protected]   
  Lead researcher: Yan Bi         
• Miami
  University of Miami
  Contact: Maria Yow [email protected]   
  Contact: Chloe Brown [email protected]   
  Lead researcher: Dan Sussman         
  Lead researcher: Nipun Merchant         
• Tampa
  Moffitt Cancer Center
  Contact: Toni Basinski 813-745-6360 [email protected]
  Lead researcher: Jenny Permuth

Illinois        

• Chicago
  University of Chicago Medicine
  Courtney Radakovitz [email protected]
  Lead researcher: Sonia Kupfer        

Kansas

• Kansas City
  Kansas University Medical Center
  Contact: Jill Torneden [email protected]
  Lead researcher: Ajay Bansal

Massachusetts

• Boston
  Massachusetts General Hospital
  Contact: Danielle Lynch [email protected]   
  Lead researcher: Daniel Chung
• Worcester
  Umass Memorial Medical Center
  Contact: Cara Gregoire [email protected]   
  Lead researcher: James Lindberg         

Michigan

• Ann Arbor
  University of Michigan
  Contact: Sarah Volk [email protected]   
  Contact: Erika Koeppe [email protected]   
  Lead researcher: Elena Stoffel         
  Lead researcher: Rich Kwon  
• Royal Oak
  Beaumont Health
  Contact: Tara Rangarajan [email protected]   
  Contact: Jennifer Roye [email protected]    
  Lead researcher: Dana Zakalik

Nebraska

• Omaha
  University of Nebraska Medical Center
  Contact: Suzanne Wessling  [email protected]   
  Lead researcher: Kelsey Klute      

New York

• New York
  New York University Langone Health
  Contact: Jessica Everett [email protected]   
  Contact: Jennifer Chun Kim [email protected]   
  Lead researcher: Diane Simeone, MD         
• New York
  Icahn School of Medicine At Mount Sinai
  Contact: Arielle Labiner [email protected]   
  Lead researcher: Aimee Lucas         
• New York
  Columbia University Irving Medical Center
  Contact: Tiffany Lam [email protected]   
  Principal Investigator: Fay Kastrinos        
• Rochester 
  University of Rochester Medical Center
  Contact: Krystle Bittner [email protected]   
  Lead researcher: Darren Carpizo         
  Lead researcher: Vivek Kaul         

Ohio

• Columbus
  The Ohio State University
  Contact: Philip Hart [email protected]
  Lead researcher: Philip Hart

Oregon

• Portland
  Oregon Health & Science University
  Contact: Dove Keith [email protected]   
  Lead researcher: Aaron Grossberg         
  Lead researcher: Brett Sheppard         
  Lead researcher: Rosie Sears         

Pennsylvania

• Philadelphia
  Fox Chase Cancer Center
  Contact: Sara Snell [email protected]
  Lead researcher: David Weinberg
• Philadelphia
  University of Pennsylvania
  Contact: Danny Clay [email protected]   
  Lead researcher: Bryson Katona         
• Pittsburgh
  University of Pittsburgh Medical Center (Upmc)
  Contact: Beth Dudley [email protected]   
  Lead researcher: Randy Brand         

Texas

• Dallas
  The University of Texas Southwestern Medical Center
  Contact: Blake Foley [email protected]
  Contact: Christofer Bishop [email protected]
  Lead researcher: Nisa Kubiliun
• Houston
  MD Anderson Center
  Contact: Seyda Baydigan [email protected]   
  Lead researcher: Florencia McAllister         

Utah

• Saint George
  Intermountain Health
  Contact Ted May [email protected]
  Lead researcher: Maricel Purcell
• Salt Lake City
  Huntsman Cancer Institute
  Contact: Jonathan Crites [email protected]  
  Lead researcher: Joanne Jeter         

Virginia

• Fairfax
  Inova Schar Cancer Institute
  Contact: Stephanie Van Bebber 571-472-4724 [email protected]   
  Lead researcher: Raymond Wadlow
• Richmond
  VCU Massey Cancer Center
  Contact: Nicole Knight [email protected] 
  Lead researcher: Jose Trevino        

Washington

• Seattle
  University of Washington
  Contact: Lisa Ann Lai       [email protected]   
  Lead researcher: Teri Brentnall  

Additional sites are open in Canada, Israel, Italy, Spain, and the United Kingdom. See clinicaltrials.gov for the full list of open sites.        

The study will enroll people from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE study:

Group 1:

Individuals without personal diagnosis of PDAC meeting any of the following criteria:

• 2 or more relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age: 50 or older or 10 or more years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with pancreatic cancer; age: 50 or older or 10 years younger than earliest pancreatic cancer  in family
• Inherited mutation in BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest pancreatic cancer in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with inherited mutation in CDKN2A; age: 40 or older
• Peutz-Jegher syndrome with an inherited STK11 mutation; age: 35 or older
• Hereditary pancreatitis with and inherited PRSS1 mutation and history of pancreatitis; age: 40 or older

Group 2

Individuals without a personal diagnosis  of PDAC meeting any of the following criteria:

• ATM, BRCA1, BRCA2, or PALB2 inherited mutation regardless of family history, age: 50 or older
• 2+ relatives with pancreatic cancer on the same side of family, any degree of relation, not meeting other criteria above; age: 50 or older or 10 years younger than earliest pancreatic cancer in family
• 1 first degree relative with pancreatic cancer at or younger than age 45; age: up to 10 years younger than PDAC diagnosis in family member

Group 3

• Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)

Group 4

• Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Group 5

• Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.

Group 6

Individuals with a personal history of PDAC meeting any of the following criteria:

• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45

Cyst Group

• Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)

Individuals not meeting the criteria above are not eligible to participate.