Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000421538p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2024
Date registered
8/04/2024
Date last updated
8/04/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
APRISE Program - Australian Pancreatic High-RIsk ScrEening Program for individuals who are at high risk of developing pancreatic cancer due to familial or genetic risk factors
Scientific title
Assess the effectiveness of the Australian Pancreatic High-RIsk ScrEening Program in identifying early-stage pancreatic cancer among high-risk individuals due to familial or genetic risk factors
Secondary ID [1] 311640 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer
 333085 0
Condition category
Condition code
Cancer 329780 329780 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The APRISE Program is a new surveillance 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. All participants will be offered genetic counselling as per standard of care, and a referral can be made at any time of the study.

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.
Intervention code [1] 328103 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337551 0
To assess the effectiveness of pancreatic surveillance protocols in identifying early-stage pancreatic cancer among high-risk individuals.
Timepoint [1] 337551 0
Baseline and annually, for a total follow-up period of 10 years. If an abnormal finding is observed during this time, repeat EUS/MRI will be performed every 3-6 months as advised by the treating physician. Follow-up, including assessments, will be stopped upon diagnosis of cancer, or death, whichever occurs first. Should a participant be diagnosed with pancreatic cancer during the study, they will have the opportunity to consent to a separate study that is specifically designed for individuals diagnosed with pancreatic cancer as a result of surveillance.
Secondary outcome [1] 432304 0
To determine the prevalence and stage of early PDAC in asymptomatic high-risk individuals.
Timepoint [1] 432304 0
Baseline and annually, for a total follow-up period of 10 years. If an abnormal finding is observed during this time, repeat EUS/MRI will be performed every 3-6 months as advised by the treating physician. Follow-up, including assessments, will be stopped upon diagnosis of cancer, or death, whichever occurs first. Should a participant be diagnosed with pancreatic cancer during the study, they will have the opportunity to consent to a separate study that is specifically designed for individuals diagnosed with pancreatic cancer as a result of surveillance.
Secondary outcome [2] 432305 0
To determine the effect of pancreatic cancer surveillance on quality of life and cancer worry. This will be analysed as a composite secondary outcome.
Timepoint [2] 432305 0
Baseline and annually, for a total follow-up period of 10 years. Follow-up, including assessments, will be stopped upon diagnosis of cancer, or death, whichever occurs first. Should a participant be diagnosed with pancreatic cancer during the study, they will have the opportunity to consent to a separate study that is specifically designed for individuals diagnosed with pancreatic cancer as a result of surveillance.
Secondary outcome [3] 432923 0
To determine the prevalence and stage of early pre-cursor lesions in asymptomatic high-risk individuals.
Timepoint [3] 432923 0
Baseline and annually, for a total follow-up period of 10 years. If an abnormal finding is observed during this time, repeat EUS/MRI will be performed every 3-6 months as advised by the treating physician. Follow-up, including assessments, will be stopped upon diagnosis of cancer, or death, whichever occurs first. Should a participant be diagnosed with pancreatic cancer during the study, they will have the opportunity to consent to a separate study that is specifically designed for individuals diagnosed with pancreatic cancer as a result of surveillance.

Eligibility
Key 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).

Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are considered clinically unfit to undergo surveillance by EUS or MRI.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315964 0
Government body
Name [1] 315964 0
The Victorian Government through the Victorian Cancer Agency
Country [1] 315964 0
Australia
Funding source category [2] 315965 0
Charities/Societies/Foundations
Name [2] 315965 0
Pancreatic Cancer Research Foundation - PanKind Australia
Country [2] 315965 0
Australia
Funding source category [3] 315966 0
Hospital
Name [3] 315966 0
Jreissati Pancreatic Centre at Epworth HealthCare
Country [3] 315966 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
Country
Australia
Secondary sponsor category [1] 318106 0
Charities/Societies/Foundations
Name [1] 318106 0
Pancreatic Cancer Research Foundation - PanKind Australia
Address [1] 318106 0
Country [1] 318106 0
Australia
Secondary sponsor category [2] 318107 0
Government body
Name [2] 318107 0
The Victorian Government through the Victorian Cancer Agency
Address [2] 318107 0
Country [2] 318107 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314789 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 314789 0
Ethics committee country [1] 314789 0
Australia
Date submitted for ethics approval [1] 314789 0
20/03/2024
Approval date [1] 314789 0
Ethics approval number [1] 314789 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132738 0
A/Prof Andrew Metz
Address 132738 0
Jreissati Pancreatic Centre at Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132738 0
Australia
Phone 132738 0
+61 3 94266777
Fax 132738 0
Email 132738 0
[email protected]
Contact person for public queries
Name 132739 0
The Jreissati Pancreatic Centre at Epworth
Address 132739 0
Jreissati Pancreatic Centre at Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132739 0
Australia
Phone 132739 0
+61 3 94268880
Fax 132739 0
Email 132739 0
[email protected]
Contact person for scientific queries
Name 132740 0
The Jreissati Pancreatic Centre at Epworth
Address 132740 0
Jreissati Pancreatic Centre at Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132740 0
Australia
Phone 132740 0
+61 3 94268880
Fax 132740 0
Email 132740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.