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Pancreatic Cancer Early Detection for People at High Risk

Clinicaltrials.gov identifier:
NCT04970056

Prevention
Registry and biobank for high risk people undergoing pancreatic cancer screening

Study Contact Information:

For additional information, contact:
Contact: Naveen Fawas: 734-665-4108  naveen.fawaz@arborresearch.org
Contact: John Graff, PhD:  734-665-4108  john.graff@arborresearch.org

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 ().

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 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 , 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 risk at any of the participating sites can be offered participation in the PRECEDE study:

Group 1:

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

  • 2 or more relatives with 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 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
  • in , , , , , , , , 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 in CDKN2A; age: 40 or older
  • Peutz-Jegher syndrome with an inherited 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 meeting any of the following criteria:

  • , , , or 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 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 presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Group 5

  • Individuals without history of 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 meeting any of the following criteria:

  • Family history includes at least one first degree relative with , or 2 relatives with who are first degree related to each other
  • Personal or family history of a pathogenic or likely pathogenic germline variant in , , , CDKN2A, , , , , ,PMS2, PRSS1,
  • 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 , no known pathogenic germline variants linked to 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  miles.picus@providence.org
    Lead researcher: Ora Gordan
  • Duarte
    City of Hope
    Contact: Diamond Ward diward@coh.org   
    Lead researcher: James Lin         
    Lead researcher: Greg Idos         
  • La Jolla
    UC San Diego Moores Cancer Center
    Contact: Shirley Sarno stsarno@health.ucsd.edu   
    Lead researcher: Andy Lowy         
    Lead researcher: Joy Liau         
  • Los Angeles
    Cedars-Sinai Medical Center
    Contact: Liliana Bancila 310-423-3872 liliana.bancila@cshs.org   
    Lead researcher: Srinivas Gaddam   
  • Los Angeles
    UCLA Health
    Contact: Aletta Deranterisassian anderanteriassian@mednet.ucla.edu     
    Lead researcher: Timthy Donahue
  • Sacramento
    UC Davis
    Contact: Anthony Martinez axmartinez@ucdavis.edu
    Lead researcher: Edward Kim
  • San Francisco
    University of California, San Francisco (UCSF)
    Contact: Kurt Giles pancreasCRC@ucsf.edu

Connecticut

  • New Haven
    Yale University
    Contact: Scott Merenda scott.merenda@yale.edu   
    Lead researcher: James Farrell         

Florida

  • Jacksonville
    Mayo Clinic, Jacksonville
    Contact: Guillermo Pradieu Pradieu.Guillermo@mayo.edu   
    Lead researcher: Yan Bi         
  • Miami
    University of Miami
    Contact: Maria Yow mvy6@med.miami.edu   
    Contact: Chloe Brown cmb482@med.miami.edu   
    Lead researcher: Dan Sussman         
    Lead researcher: Nipun Merchant         
  • Tampa
    Moffitt Cancer Center
    Contact: Toni Basinski 813-745-6360 Toni.Basinski@Moffitt.org
    Lead researcher: Jenny Permuth

Illinois        

Kansas

  • Kansas City
    Kansas University Medical Center
    Contact: Jill Torneden jtorneden2@kumc.edu
    Lead researcher: Ajay Bansal

Massachusetts

  • Boston
    Massachusetts General Hospital
    Contact: Danielle Lynch dlynch22@mgh.harvard.edu   
    Lead researcher: Daniel Chung
  • Worcester
    Umass Memorial Medical Center
    Contact: Cara Gregoire Cara.Gregoire@umassmed.edu   
    Lead researcher: James Lindberg         

Michigan

Nebraska

  • Omaha
    University of Nebraska Medical Center
    Contact: Suzanne Wessling  suzanne.wessling@unmc.edu   
    Lead researcher: Kelsey Klute      

New York

  • New York
    New York University Langone Health
    Contact: Jessica Everett Jessica.Everett@nyulangone.org   
    Contact: Jennifer Chun Kim Jennifer.ChunKim@nyulangone.org   
    Lead researcher: Diane Simeone, MD         
  • New York
    Icahn School of Medicine At Mount Sinai
    Contact: Arielle Labiner arielle.labiner@mssm.edu   
    Lead researcher: Aimee Lucas         
  • New York
    Columbia University Irving Medical Center
    Contact: Tiffany Lam tl3141@cumc.columbia.edu   
    Principal Investigator: Fay Kastrinos        
  • Rochester 
    University of Rochester Medical Center
    Contact: Krystle Bittner Krystle_Bittner@URMC.Rochester.edu   
    Lead researcher: Darren Carpizo         
    Lead researcher: Vivek Kaul         

Ohio

  • Columbus
    The Ohio State University
    Contact: Philip Hart Philip.Hart@osumc.edu
    Lead researcher: Philip Hart

Oregon

  • Portland
    Oregon Health & Science University
    Contact: Dove Keith keithd@ohsu.edu   
    Lead researcher: Aaron Grossberg         
    Lead researcher: Brett Sheppard         
    Lead researcher: Rosie Sears         

Pennsylvania

  • Philadelphia
    Fox Chase Cancer Center
    Contact: Sara Snell sara.snell@fccc.edu
  • Lead researcher: David Weinberg
  • Philadelphia
    University of Pennsylvania
    Contact: Danny Clay Daniel.Clay@Pennmedicine.upenn.edu   
    Lead researcher: Bryson Katona         
  • Pittsburgh
    University of Pittsburgh Medical Center (Upmc)
    Contact: Beth Dudley dudleyre@upmc.edu   
    Lead researcher: Randy Brand         

Texas

Utah

  • Saint George
    Intermountain Health
    Contact Ted May Ted.May@imail.org
    Lead researcher: Maricel Purcell
  • Salt Lake City
    Huntsman Cancer Institute
    Contact: Jonathan Crites jonathan.crites@hci.utah.edu  
    Lead researcher: Joanne Jeter         

Virginia

  • Fairfax
    Inova Schar Cancer Institute
    Contact: Stephanie Van Bebber 571-472-4724 Stephanie.VanBebber@inova.org   
    Lead researcher: Raymond Wadlow
  • Richmond
    VCU Massey Cancer Center
    Contact: Nicole Knight nknight@vcu.edu 
    Lead researcher: Jose Trevino        

Washington

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

This Study is Open To:

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

Group 1:

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

  • 2 or more relatives with 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 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
  • in , , , , , , , , 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 in CDKN2A; age: 40 or older
  • Peutz-Jegher syndrome with an inherited 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 meeting any of the following criteria:

  • , , , or 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 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 presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.

Group 5

  • Individuals without history of 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 meeting any of the following criteria:

  • Family history includes at least one first degree relative with , or 2 relatives with who are first degree related to each other
  • Personal or family history of a pathogenic or likely pathogenic germline variant in , , , CDKN2A, , , , , ,PMS2, PRSS1,
  • 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 , no known pathogenic germline variants linked to risk)
This Study is Not Open To:

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