Studies blood, immune and gut markers in unresectable pancreatic cancer
Collects blood and stool samples from adults with inoperable pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer
Key facts
- Where
- Taoyuan, TaiwanSee the site
Where in Taiwan
- Linkou Chang Gung Memorial HospitalTaoyuan, TaiwanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chang Gung Memorial Hospital
- Trial code
- NCT07036978
- Record updated
- 15 April 2026
- Original description
Brief SummaryRead full original descriptionShow less
Integrative Metabolomic and Immune-Microbiome Profiling for Personalised Treatment Stratification in Unresectable Pancreatic Cancer
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.
Inclusion: Unresectable disease status determined by a multidisciplinary tumour board (either locally advanced disease encasing critical vessels or distant metastases present); 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; 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; 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: Prior systemic therapy for metastatic PDAC; Co-existing active malignancy that could confound metabolomic or immune readouts, unless it is a low-grade, early cancer in remission; 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).