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 [email protected]
Contact: John Graff, PhD: 734-665-4108 [email protected]
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 variant in , , , , , , , , ,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 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.
Arizona
City: Scottsdale RECRUITING
Facility: Honor Health Research Institute
Contact Info:
[email protected]
Erkut Borazanci, MD
California
City: Burbank RECRUITING
Facility: Providence Health and Services
Contact Info:
[email protected]
Ora Gordon, MD, MS. FACMG
City: Duarte RECRUITING
Facility: City of Hope
Contact Info:
[email protected]
James Lin
Greg Idos
City: La Jolla RECRUITING
Facility: UC San Diego Moores Cancer Center
Contact Info:
[email protected]
Andy Lowy
Joy Liau
Diane Simeone
City: Los Angeles RECRUITING
Facility: Cedars-Sinai Medical Center
Contact Info:
[email protected]
310-423-3872
Srinivas Gaddam
City: Los Angeles RECRUITING
Facility: UCLA Health
Contact Info:
[email protected]
Timothy Donahue, MD
City: Sacramento RECRUITING
Facility: UC Davis
Contact Info:
[email protected]
Edward Kim, MD, PhD
City: San Francisco RECRUITING
Facility: University of California, San Francisco (UCSF)
Contact Info:
[email protected]
Margaret Tempero, MD
Connecticut
City: New Haven RECRUITING
Facility: Yale University
Contact Info:
[email protected]
James Farrell
Florida
City: Jacksonville RECRUITING
Facility: Mayo Clinic Jacksonville
Contact Info:
[email protected]
Yan Bi
City: Miami RECRUITING
Facility: University of Miami
Contact Info:
[email protected]
[email protected]
Dan Sussman
Nipun Merchant
City: Tampa RECRUITING
Facility: Moffitt Cancer Center
Contact Info:
[email protected]
813-745-6360
Jenny Permuth
Illinois
City: Bloomington RECRUITING
Facility: Illinois CancerCare
Contact Info:
[email protected]
Kimberly Ku, MD
City: Chicago RECRUITING
Facility: University of Chicago Medicine
Contact Info:
[email protected]
Sonia Kupfer, MD
City: Evanston RECRUITING
Facility: NorthShore University HealthSystem
Contact Info:
[email protected]
Melissa Hogg, MD
Kansas
City: Kansas City RECRUITING
Facility: University of Kansas Medical Center
Contact Info:
[email protected]
Ajay Bansal, MD
Massachusetts
City: Boston RECRUITING
Facility: Massachusetts General Hospital
Contact Info:
[email protected]
Daniel Chung
City: Worcester RECRUITING
Facility: Umass Memorial Medical Center
Contact Info:
[email protected]
James Lindberg, MD
Michigan
City: Ann Arbor RECRUITING
Facility: University of Michigan
Contact Info:
[email protected]
[email protected]
Elena Stoffel
Rich Kwon
City: Royal Oak RECRUITING
Facility: Beaumont/Corewell Health
Contact Info:
[email protected]
Dana Zakalik, MD
Nebraska
City: Omaha RECRUITING
Facility: University of Nebraska Medical Center
Contact Info:
[email protected]
Kelsey Klute
New Jersey
City: Hackensack RECRUITING
Facility: Hackensack Meridian Health
Contact Info:
[email protected]
Rosario Ligresti, MD
New York
City: New York RECRUITING
Facility: Icahn School of Medicine At Mount Sinai
Contact Info:
[email protected]
[email protected]
Aimee Lucas
City: New York RECRUITING
Facility: Columbia University Irving Medical Center
Contact Info:
[email protected]
Fay Kastrinos
City: Rochester RECRUITING
Facility: University of Rochester Medical Center
Contact Info:
[email protected]
Darren Carpizo
Vivek Kaul
City: White Plains RECRUITING
Facility: White Plains Hospital
Contact Info:
[email protected]
Joshua Raff, MD
Ohio
City: Columbus RECRUITING
Facility: The Ohio State University
Contact Info:
[email protected]
Philip Hart, MD
Oregon
City: Portland RECRUITING
Facility: Oregon Health & Science University
Contact Info:
[email protected]
Aaron Grossberg
Brett Sheppard
Rosie Sears
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
[email protected]
Bryson Katona
City: Philadelphia RECRUITING
Facility: Fox Chase Cancer Center
Contact Info:
[email protected]
David Weinberg, MD, MSc
City: Pittsburgh RECRUITING
Facility: University of Pittsburgh Medical Center (Upmc)
Contact Info:
[email protected]
Randy Brand
Tennessee
City: Knoxville RECRUITING
Facility: University of Tennessee Graduate School of Medicine
Contact Info:
[email protected]
James McLoughlin, MD
Texas
City: Dallas RECRUITING
Facility: The University of Texas Southwestern Medical Center
Contact Info:
[email protected]
Nisa Kubiliun, MD
Utah
City: Saint George RECRUITING
Facility: Intermountain Health
Contact Info:
[email protected]
Maricel Purcell, APRN
City: Salt Lake City RECRUITING
Facility: Huntsman Cancer Institute
Contact Info:
[email protected]
Whitney Espinel, MMSc, GC
Virginia
City: Fairfax RECRUITING
Facility: Inova Schar Cancer Institute
Contact Info:
[email protected]
571-472-4724
Raymond Wadlow, MD
City: Richmond RECRUITING
Facility: VCU Massey Comprehensive Cancer Center
Contact Info:
[email protected]
Jose Trevino, MD
Washington
City: Seattle RECRUITING
Facility: University of Washington
Contact Info:
[email protected]
Teri Brentnall
Other Countries
Country: Australia
State: Victoria
City: Richmond RECRUITING
Facility: Epworth HealthCare
Contact Info:
[email protected]
Andrew Metz, MBBS, FRACP
Country: Canada
State: British Columbia
City: Vancouver RECRUITING
Facility: British Columbia Cancer Agency
Contact Info:
[email protected]
Intan Schrader
Country: Canada
State: Ontario
City: Toronto RECRUITING
Facility: University Health Network
Contact Info:
[email protected]
Robert Grant
Country: Canada
State: Quebec
City: Montreal RECRUITING
Facility: McGill University Health Centre
Contact Info:
[email protected]
George Zogopoulos
Country: Hungary
City: Budapest RECRUITING
Facility: Semmelweis University, Institute of Pancreatic Diseases
Contact Info:
[email protected]
Péter Hegyi, MD, PhD, DSc
Country: Iceland
City: Reykjavík RECRUITING
Facility: Landspitali University Hospital
Contact Info:
[email protected]
Sigurdís Haraldsdóttir, MD
Country: Israel
City: Ramat Gan RECRUITING
Facility: Sheba Medical Center
Contact Info:
[email protected]
Talia Golan
Ido Laish
Eitan Friedman
Country: Italy
City: Verona RECRUITING
Facility: Azienda Ospedaliera Universitaria Integrata Verona
Contact Info:
[email protected]
[email protected]
Salvatore Paiella
Country: Singapore
City: Singapore RECRUITING
Facility: National Cancer Centre Singapore
Contact Info:
[email protected]
[email protected]
Joanne Ngeow
Country: Spain
City: Barcelona RECRUITING
Facility: Hospital Clínic de Barcelona
Contact Info:
[email protected]
Eva C Vaquero, MD, PhD
Leticia Moreira, MD, PhD
Country: Spain
City: Madrid RECRUITING
Facility: Ramón y Cajal University Hospital
Contact Info:
[email protected]
Julie Earl
Country: Taiwan
State: Taiwan T.o.c.
City: Tainan RECRUITING
Facility: National Cheng Kung University Hospital (NCKUH)
Contact Info:
[email protected]
Yan-Shen Shan
Country: United Kingdom
City: Liverpool RECRUITING
Facility: University of Liverpool
Contact Info:
[email protected]
Bill Greenhalf
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 variant in , , , , , , , , ,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 variants linked to risk)
Individuals not meeting the criteria above are not eligible to participate.