Trial Title:
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
NCT ID:
NCT06122896
Condition:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Screening Blood Tests
Description:
Carbohydrate antigen (CA) 19-9, Hemoglobin A1C (HbA1c), and Fasting blood glucose (FBG)
per standard-of-care.
Arm group label:
Pancreatic Cancer High-Risk Participants
Intervention type:
Diagnostic Test
Intervention name:
Endoscopic Ultrasound
Description:
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arm group label:
Pancreatic Cancer High-Risk Participants
Other name:
EUS
Intervention type:
Combination Product
Intervention name:
Magnetic Resonance Imaging
Description:
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arm group label:
Pancreatic Cancer High-Risk Participants
Other name:
MRI
Intervention type:
Combination Product
Intervention name:
Magnetic Resonance Cholangiopancreatography
Description:
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arm group label:
Pancreatic Cancer High-Risk Participants
Other name:
MRCP
Summary:
The purpose of this research is to see if adding blood-based tests and symptom review to
standard-of-care pancreatic cancer screening procedures can identify cancer early among
individuals with increased risk.
Detailed description:
In this research study, investigators will combine blood-based tests and review of
symptoms with standard-of-care pancreatic cancer screening procedures to see if
pancreatic cancer can be detected early among individuals with increased risk. Pancreatic
cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance
Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP).
The research study procedures include screening for eligibility, questionnaires, clinic
visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance
Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples.
Participation in this research study will be a minimum of 30 months and up to 20 years
via review of medical records and the annual collection of blood and stool samples.
It is expected that about 5,000 people will take part in this research study.
This study is supported by the Hale Family Research Center at Dana-Farber Cancer
Institute.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants must meet any of the following:
- Individuals with pathogenic/likely pathogenic germline variants in STK11, and age
≥30 years.
- Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age
≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer
diagnosis in the family, whichever is earlier).
- Individuals with pathogenic/likely pathogenic germline variants in one of the other
pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM,
PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine
pancreatic cancer diagnosis in the family, whichever is earlier) AND
• Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same
side of (or presumed to be from the same side of) the family as the identified
pathogenic/likely pathogenic germline variant.
- Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical
phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years
after onset of pancreatitis, whichever is earlier).
- Individuals with familial pancreatic cancer including:
- Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from
the same side of the family, even in the absence of a known pathogenic/likely
pathogenic germline variant, OR
- Family history of exocrine pancreatic cancer in 1 affected first-degree
relative and 1 second-degree relative, even in the absence of a known
pathogenic/likely pathogenic germline variant, OR
- Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree
relatives from the same side of the family, even in the absence of a known
pathogenic/likely pathogenic germline variant.
- Individuals who are undergoing clinically recommended pancreatic cancer
surveillance.
Exclusion Criteria:
- Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
- Individuals with any active metastatic cancer.
- Individuals who are unable to give informed consent.
- Individuals who are under the age of 18 (infants, children, teenagers).
- Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance
Cholangiopancreatography and Endoscopic Ultrasound.
- Pregnant women are unlikely to be undergoing screening procedures and will not be
considered eligible but can consent to the study at a later date.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Matthew Yurgelun, MD
Phone:
617-582-8673
Email:
matthew_yurgelun@dfci.harvard.edu
Investigator:
Last name:
Matthew Yurgelun, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Yurgelun, MD
Phone:
617-582-8673
Email:
matthew_yurgelun@dfci.harvard.edu
Investigator:
Last name:
Matthew B Yurgelun, MD
Email:
Principal Investigator
Start date:
November 21, 2023
Completion date:
October 31, 2041
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06122896
