Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Prior systemic therapy for metastatic PDAC.
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).
Co-existing active malignancy that could confound metabolomic or immune readouts, unless it is a low-grade, early cancer in remission.
Trial design
Treatments tested in this trial
- Collecting biospecimens
Treatment groups
140 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov