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
This trial does not accept healthy volunteersQualifiers
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 population
The study will enrol adult patients (age ≥18) with unresectable pancreatic ductal adenocarcinoma, including both locally advanced PDAC (not amenable to surgical resection) and metastatic PDAC. All patients must have histologically or cytologically confirmed pancreatic adenocarcinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collecting biospecimens
Other interventionCollecting blood, urine, tissue, and faecal samples
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Pancreatic Cancer1 intervention
Trial outcomes
Primary outcomes
1
Treatment response classification based on metabolomic profiles
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.
Time frame
At baseline (prior to treatment initiation) and at first radiographic evaluation (8-12 weeks after treatment initiation).Secondary outcomes
1
Correlation between immune-microbiome landscape and treatment outcomes
Immune cell phenotyping and 16S rRNA microbiome sequencing will be conducted to identify immunological and microbial profiles associated with clinical response and progression-free survival.
Time frame
At baseline (prior to treatment initiation); progression-free survival assessed through study completion (up to 18 months).Other outcomes
1
Development of a multi-parameter stratification model
An integrative prediction model combining metabolomic, immune, and microbiome data will be developed and tested for its accuracy in stratifying patients based on expected treatment response and survival.
Time frame
Model development and internal validation to be completed by study end (up to 30 months after first patient enrollment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: