Pancreatic Cancer Early Detection for People at High Risk
https://www.facingourrisk.org/research-clinical-trials/study/227/pancreatic-cancer-early-detection-for-people-at-high-risk
Clinicaltrials.gov identifier:
NCT04970056 (https://clinicaltrials.gov/show/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
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 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
- Chicago
University of Chicago Medicine
Courtney Radakovitz cradakovitz1@bsd.uchicago.edu
Lead researcher: Sonia Kupfer
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
- Ann Arbor
University of Michigan
Contact: Sarah Volk stomanic@med.umich.edu
Contact: Erika Koeppe eskoeppe@med.umich.edu
Lead researcher: Elena Stoffel
Lead researcher: Rich Kwon - Royal Oak
Beaumont Health
Contact: Tara Rangarajan tara.rangarajan@beaumont.org
Contact: Jennifer Roye jennifer.roye@beaumont.org
Lead researcher: Dana Zakalik
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
- Dallas
The University of Texas Southwestern Medical Center
Contact: Blake Foley samantha.foley@utsouthwestern.edu
Contact: Christofer Bishop christofer.bishop@utsouthwestern.edu
Lead researcher: Nisa Kubiliun - Houston
MD Anderson Center
Contact: Seyda Baydigan FMcAllister@mdanderson.org
Lead researcher: Florencia McAllister
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
- Seattle
University of Washington
Contact: Lisa Ann Lai LLai@medicine.washington.edu
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.
This Study is Open To:
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)
This Study is Not Open To:
Individuals not meeting the criteria above are not eligible to participate.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.