Clinical trial NCT06122896: Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
Official title: Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm
Keywords: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Primary outcomes:
measure: Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
timeFrame: 6-monthly for 3 years with 5-year follow-up
measure: Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
timeFrame: 6-monthly for 3 years with 5-year follow-up
measure: Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
timeFrame: 6-monthly for 3 years with 5-year follow-up
Secondary outcomes:
measure: Positive Predictive Value of Blood Assays
timeFrame: 6-monthly for 3 years
measure: Negative Predictive Value of Blood Assays
timeFrame: 6-monthly for 3 years
measure: Proportion of Screen-Detected, Resected Pancreatic Lesions
timeFrame: 6-monthly for 3 years
measure: Proportion of Non-Worrisome Pancreatic Lesions
timeFrame: 6-monthly for 3 years
measure: Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
timeFrame: 6-monthly for 3 years
measure: Number of False-Positive Assay Results
timeFrame: 6-monthly for 3 years
measure: Number of Non-PDAC Cancer Diagnoses
timeFrame: 6-monthly for 3 years
measure: Clinical Predictors of Neoplastic Development
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew Yurgelun, MD
role: PRINCIPAL_INVESTIGATOR
References: