None listed
Conditions
Brief summary
This study assesses the effectiveness of pancreatic screening in identifying early-stage pancreatic cancer among high-risk individuals. Significant emphasis is also placed on assessing the psychological perception of cancer surveillance and understanding its impact on high-risk populations. Who is it for? You may be eligible for this study if you are have relatives with history of PDAC, or high-risk pathogenic variants within the family. Study details Participants will undergo monitoring via endoscopic ultrasound or MRI to detect changes in the pancreas, for a period of 10 years. Participants will be asked to complete an eligibility questionnaire, an enrolment questionnaire and then follow-up questionnaires annually which include updates to the participant’s medical information, relevant risk factors associated with pancreatic cancer, and assessments to determine quality of life, as well as cancer risk perception and worry. It is hoped that findings from this study will help improve the prognosis of pancreatic cancer by diagnosing precursor lesions or cancer in its early and asymptomatic stage, when surgery provides the best chance for a cure.
Interventions
The APRISE Program is a national program that will screen individuals who are considered high-risk of developing pancreatic cancer.
Candidates may reach out to the study team directly or receive information through their healthcare providers, including Familial Cancer Clinics (FCCs), GPs, gastroenterologists, surgeons, clinical geneticists, and oncologists. Candidates for surveillance will require a referral from healthcare providers, including but not limited to Familial Cancer Clinics (FCCs),
The APRISE Program is a national program that will screen individuals who are considered high-risk of developing pancreatic cancer. Candidates may reach out to the study team directly or receive information through their healthcare providers, including Familial Cancer Clinics (FCCs), GPs, gastroenterologists, surgeons, clinical geneticists, and oncologists. Candidates for surveillance will require a referral from healthcare providers, including but not limited to Familial Cancer Clinics (FCCs), GPs, gastroenterologists, surgeons, clinical geneticists, and oncologists. OVERVIEW OF INTERVENTIONS: Individuals considered at high risk for developing pancreatic ductal adenocarcinoma (PDAC) based on a history of: • One or more family members with PDAC and/or • A pathogenic or likely pathogenic germline variant in a gene linked to PDAC risk Will undergo monitoring via endoscopic ultrasound or MRI for a period of 10 years, with the follow-up concluding at 10 years, upon diagnosis of pancreatic cancer, or death (whichever occurs first). Participants will have the choice of either an EUS or MRI after consultation with their healthcare team and availability of imaging modalities at their site. Each EUS/MRI session will take approximately 1 hour and repeated annually. Medical records will be used to monitor adherence to the protocol. Participants will also be asked to complete questionnaires throughout the study. Each questionnaire will take about 30 minutes to complete, and participants can return it electronically via email, or by using a reply-paid envelope that will be provided to them: 1. Individuals who are interested in participating in the study will be asked to complete an Eligibility Questionnaire, which will request details of their family and medical history. 2. The Enrolment Questionnaire will include details of the participant’s medical history, relevant risk factors associated with pancreatic cancer, and an Impact of Events and Personal Consequences scale to assess quality of life, as well as cancer risk perception and worry. 3. A Follow-Up Questionnaire will be completed annually. The Follow-up Questionnaire will include updates to the participant’s medical information, relevant risk factors associated with pancreatic cancer, and an Impact of Events and Personal Consequences scale to assess quality of life, as well as cancer risk perception and worry.
Sponsors
Epworth HealthCare
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Individuals aged 18 to 90 years old (inclusive) without history of PDAC meeting any of the following criteria: a) 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 and age 50+ years or 10 years younger than earliest PDAC in family at time of diagnosis. b) 2 or more affected first degree relatives with PDAC and age 50+ or 10 years younger than earliest PDAC in family. c) BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant and 1 first or second degree relative with PDAC and age 50+ or 10 years younger than earliest PDAC in family. d) Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant and age 40+. e) Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant and age 35+. f) Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis and age 40+ or 20 years after onset of pancreatitis (whichever is earlier).
Exclusion criteria
Participants will be excluded if they are considered clinically unfit to undergo surveillance by EUS or MRI.
Outcome results
None listed