Collecting biospecimens: Collecting blood, urine, tissue, and faecal samples
Study summary
Brief Summary
The goal of this observational study is to identify biomarkers and develop a personalised treatment stratification model for patients with unresectable pancreatic ductal adenocarcinoma (PDAC) in Taiwan. The main questions it aims to answer are:
* What serum metabolomic profiles predict treatment response and patient survival?
* How do immune response markers and gut microbiome composition correlate with therapeutic outcomes?
* Can a combined multi-omic stratification algorithm enhance personalised therapy planning?
Participants, who have been diagnosed with unresectable locally advanced or metastatic PDAC and are undergoing systemic therapy and chemoradiotherapy, will:
* Provide serum samples for comprehensive metabolomic profiling via high-performance liquid chromatography-mass spectrometry.
* Undergo immune profiling through flow cytometry.
* Provide stool samples for gut microbiome analysis using 16S rRNA sequencing.
* Be followed longitudinally to correlate these multi-omic findings with clinical outcomes.
Researchers anticipate that integrating these multi-omic analyses will facilitate personalised therapy approaches, potentially improving patient outcomes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Unresectable disease status determined by a multidisciplinary tumour board (either locally advanced disease encasing critical vessels or distant metastases present).
2. Planned initiation of systemic therapy (first-line chemotherapy or chemo + experimental immunotherapy trial) as part of standard care - this ensures a uniform starting point for outcome measurement.
3. Adequate organ function to undergo therapy (renal, hepatic, bone marrow parameters within acceptable range) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating patients well enough to participate and undergo required blood draws and sample collection.
4. Ability to provide informed consent, with no severe comorbid conditions that would preclude study procedures (e.g. unable to provide stool sample or undergo blood draws).
Exclusion Criteria:
1. Prior systemic therapy for metastatic PDAC.
2. Current use of long-term antibiotics or probiotics that could significantly alter the gut microbiome unless they are willing to pause these interventions (to avoid confounding in microbiome analysis).
3. Co-existing active malignancy that could confound metabolomic or immune readouts, unless it is a low-grade, early cancer in remission.
Primary outcome measure(s)
Treatment response classification based on metabolomic profiles — At baseline (prior to treatment initiation) and at first radiographic evaluation (8-12 weeks after treatment initiation). Metabolite signatures will be analyzed for their association with clinical treatment response, defined by radiographic response or disease control. Profiles will be used to classify patients into metabolic phenotypes predictive of therapeutic response.
Trial sites (1)
Facility
City
Region
Status
Linkou Chang Gung Memorial Hospital
Taoyuan
Taiwan
More Chang Gung Memorial Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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