Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000831482
Ethics application status
Approved
Date submitted
1/07/2025
Date registered
4/08/2025
Date last updated
4/08/2025
Date data sharing statement initially provided
4/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a patient-reported symptom tool to identify pancreatic exocrine insufficiency in pancreatic cancer
Scientific title
Validation of a patient-reported symptom tool to identify pancreatic exocrine insufficiency in patients diagnosed with pancreatic cancer
Secondary ID [1] 314784 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic exocrine insufficiency 338020 0
Condition category
Condition code
Cancer 334332 334332 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study research assistant will administer the new Exocrine Pancreatic Insufficiency/Pancreatic Exocrine Insufficiency- Symptom Score (EPI/PEI-SS) tool online to collect information about whether people recruited to the study with pancreatic cancer have any of the 15 symptoms associated with PEI. People will be asked to articulate the frequency and severity of their symptoms as part of validating the new tool(EPI/PEI-SS). As part of the study, participants will also complete the PAN-26 assessment tool online, which includes 9 overlapping symptom questions as well as other questions related to quality of life with PC. The online tools will take approximately 12 minutes to complete. Participants will also be asked to collect a faecal sample which will then be used to diagnose PEI via faecal elastase testing.
Intervention code [1] 331384 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will also be asked to collect a faecal sample which will then be used to diagnose PEI via faecal elastase testing. The sample can be collected at any time during the data collection time period as timing is not critical.
Control group
Active

Outcomes
Primary outcome [1] 341995 0
Determine the predictive power of the simple bedside EPI/PEI-SS tool to diagnose EPI/PEI in a PC population compared to faecal elastase test results, the current clinical diagnostic practice.
Timepoint [1] 341995 0
At time of recruitment and Day 14
Secondary outcome [1] 449270 0
evaluation of point score difference between individuals with and without PEI within the pancreatic cancer population
Timepoint [1] 449270 0
At time of recruitment and Day 14

Eligibility
Key inclusion criteria
To be eligible to participate in the study, participants must have a clinical diagnosis of pancreatic cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are younger than 18 years old, if they have significant cognitive impairment, unable to read and understand English, or if they are unable to consent to/complete the survey for any reason. If the participant is unable to access the internet, paper surveys will be sent with return, self-addressed envelopes.

Study design
Purpose of the study
Diagnosis
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
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by PI Lewis using Jupyter Notebook with Python code. Descriptive statistics will be used to analyse the demographic data and to determine survey sub- and total scores. The analysis will be stratified into PEI and non-PEI pancreatic cancer groups and responses will be summarised in terms of frequency and severity. Statistical significance between groups will be determined using unpaired t-test (for parametric data) or Mann-Whitney U test (for non-parametric data), Cohen’s d will be calculated to compare effect sizes and Cronbach’s alpha will assess internal consistency.
We will employ linear regression analysis, ROC curve and AUC analysis to determine the predictive power of the EPI/PEI-SS tool relative to the results of the faecal elastase test. Correlation and regression analyses will be used to examine the performance and validity of overlapping items between the EPI/PEI-SS survey and the applicable 9 items from the PAN-26 survey. Correlation analysis will be conducted to quantify the strength and direction of the association between corresponding items across the two surveys, using Pearson correlation coefficients for normally distributed data, or Spearman’s rank correlation coefficients for non-normally distributed data. This method will determine if the items from the EPI/PEI-SS survey are consistent with those from the PAN-26 in measuring similar constructs within our target population.
Regression analysis will determine how well the overlapping PAN-26 items can predict the corresponding scores on the EPI/PEI-SS items. This will involve setting scores from the EPI/PEI-SS as dependent variables and the matching PAN-26 item scores as independent variables in multiple regression models. This approach will validate the items’ predictive ability and provide insights into the relative contribution of each item to the symptom constructs being measured. These analyses will aid in establishing the concurrent validity of the EPI/PEI-SS items, reinforcing their utility and credibility for assessing the target symptoms in clinical settings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2025
Actual
Date of last participant enrolment
Anticipated
16/03/2026
Actual
Date of last data collection
Anticipated
6/04/2026
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 27167 0
New Zealand
State/province [1] 27167 0

Funding & Sponsors
Funding source category [1] 319339 0
University
Name [1] 319339 0
University of Otago
Country [1] 319339 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321824 0
None
Name [1] 321824 0
Address [1] 321824 0
Country [1] 321824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317920 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317920 0
Ethics committee country [1] 317920 0
New Zealand
Date submitted for ethics approval [1] 317920 0
18/11/2024
Approval date [1] 317920 0
18/12/2024
Ethics approval number [1] 317920 0
2024 EXP 21874

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

Contacts
Principal investigator
Name 142558 0
Dr Amanda Landers
Address 142558 0
University of Otago, Christchurch 2 Riccarton Rd, Central Christchurch 8011
Country 142558 0
New Zealand
Phone 142558 0
+64 2041377822
Fax 142558 0
Email 142558 0
[email protected]
Contact person for public queries
Name 142559 0
Amanda Landers
Address 142559 0
University of Otago, Christchurch 2 Riccarton Rd, Central Christchurch 8011
Country 142559 0
New Zealand
Phone 142559 0
+64 2041377822
Fax 142559 0
Email 142559 0
[email protected]
Contact person for scientific queries
Name 142560 0
Amanda Landers
Address 142560 0
University of Otago, Christchurch 2 Riccarton Rd, Central Christchurch 8011
Country 142560 0
New Zealand
Phone 142560 0
+64 2041377822
Fax 142560 0
Email 142560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.