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Validation of a patient-reported symptom tool to identify pancreatic exocrine insufficiency in pancreatic cancer

Validation of a patient-reported symptom tool to identify pancreatic exocrine insufficiency in patients diagnosed with pancreatic cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000831482
Enrollment
135
Registered
2025-08-04
Start date
2025-09-22
Completion date
2026-03-16
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is seeking to validate a patient-reported symptom tool to identify pancreatic exocrine insufficiency in patients diagnosed with pancreatic cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above with a clinical diagnosis of pancreatic cancer Study details All participants in this study will complete the new Exocrine Pancreatic Insufficiency/Pancreatic Exocrine Insufficiency- Symptom Score (EPI/PEI-SS) tool online with the help of the study research assistant. 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. Participants will also be asked to collect a faecal sample within the study period of 14 days which will then be used to diagnose PEI via faecal elastase testing. This research may improve the diagnosis of PEI for clinicians by providing a simple tool for use in a clinic or at the bedside.

Interventions

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 assessm

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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

To be eligible to participate in the study, participants must have a clinical diagnosis of pancreatic cancer.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026