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 [email protected]
Contact: John Graff, PhD: 734-665-4108 [email protected]
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.
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.