Developing a blood test to diagnose pancreatic exocrine insufficiency
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
This study is trying to create a simple blood test to help diagnose pancreatic exocrine insufficiency in patients with pancreatic cancer so they can get the right treatment faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University Hospital Birmingham NHS Foundation Trust Academic / other |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT05980221 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency (PEI), a condition common in patients with pancreatic cancer. By analyzing blood samples from patients and healthy controls before and after a standardized meal, researchers aim to identify specific metabolic profiles that indicate PEI. The goal is to develop a quick, accurate, and patient-friendly blood test that can guide treatment with pancreatic enzyme replacement therapy (PERT). This approach addresses the limitations of current diagnostic methods, which are often inaccurate and time-consuming.
Who should consider this trial
Good fit: Ideal candidates include patients with pancreatic cancer, cystic fibrosis, or chronic pancreatitis who are experiencing symptoms of PEI and can tolerate an oral diet.
Not a fit: Patients with other gastrointestinal conditions, recent GI surgery, or a prognosis of less than two months may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to more accurate diagnoses of PEI, allowing for timely and effective treatment that improves patient quality of life.
How similar studies have performed: While the use of metabolomics in diagnosing PEI is a novel approach, similar studies have shown promise in utilizing metabolic profiling for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (for main pancreatic cancer cohort) * PDAC * PEI (as defined by breath test) * Tolerating oral diet Inclusion Criteria: (for CF cohort) * CF * PEI (as defined by breath test) * Tolerating oral diet Inclusion Criteria: (for CP cohort) * CP * PEI (as defined by breath test) * Tolerating oral diet Exclusion Criteria (all arms): * No other GI conditions * For each arm no evidence of the other arm conditions * For health controls, no history of CP, CF or pancreatic cancer * No GI surgery (except pancreatic resection in the pancreatic cancer cohort) * Unable to consent * Unable to travel to UHB for testing * Prognosis \< 2months * Performance status 2+
Where this trial is running
Birmingham
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Keith Roberts, PhD — University Hospital Birmingham NHS Foundation Trust
- Study coordinator: Sarah Powell-Brett, MBChB
- Email: sarah.powell-brett1@nhs.net
- Phone: 07887754856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.