RECRUITING

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Quick Facts

Study Start:2023-11-21

Study Completion:2041-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06122896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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
* 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.

* 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.

Contacts and Locations

Study Contact

Matthew Yurgelun, MD

CONTACT

617-582-8673

matthew_yurgelun@dfci.harvard.edu

Principal Investigator

Matthew Yurgelun, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Matthew Yurgelun, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21

Study Completion Date2041-10-31

Study Record Updates

Study Start Date2023-11-21

Study Completion Date2041-10-31

Terms related to this study

Keywords Provided by Researchers

Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm

Additional Relevant MeSH Terms

Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasm