Clinical trial
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
Name
23-147
Description
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.
Trial arms
Trial start
2023-11-21
Estimated PCD
2040-10-31
Trial end
2041-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Screening Blood Tests
Carbohydrate antigen (CA) 19-9, Hemoglobin A1C (HbA1c), and Fasting blood glucose (FBG) per standard-of-care.
Arms:
Pancreatic Cancer High-Risk Participants
Endoscopic Ultrasound
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arms:
Pancreatic Cancer High-Risk Participants
Other names:
EUS
Magnetic Resonance Imaging
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arms:
Pancreatic Cancer High-Risk Participants
Other names:
MRI
Magnetic Resonance Cholangiopancreatography
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Arms:
Pancreatic Cancer High-Risk Participants
Other names:
MRCP
Size
5000
Primary endpoint
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
6-monthly for 3 years with 5-year follow-up
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
6-monthly for 3 years with 5-year follow-up
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
6-monthly for 3 years with 5-year follow-up
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5000, 'type': 'ESTIMATED'}}
Updated at
2024-02-28
1 organization
2 products
3 indications
Organization
Dana-Farber Cancer InstituteProduct
Magnetic Resonance ImagingIndication
Pancreatic CancerIndication
Pancreatic Ductal AdenocarcinomaIndication
PDAC