Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer

NCT07036978 | Not Yet Recruiting

• 1 other identifier: 202500693B0
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Pancreatic ductal adenocarcinoma; Metabolomics; Microbiome; Immune profiling; Multi-omic integration

Outcome Measures

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.

  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

  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

  Model development and internal validation to be completed by study end (up to 30 months after first patient enrollment).

Study Arms (1)

Pancreatic Cancer

Surgically Unresectable Pancreatic Cancer

Other: Collecting biospecimens

Interventions

Collecting biospecimens OTHER

Collecting blood, urine, tissue, and faecal samples

Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, faecal, and tissue samples

Central Study Contacts

Eric Yi-Liang Shen, MD, PhD

CONTACT

886-975366392; pts@cgmh.org.tw

Yu-Hsien Chou, MS

CONTACT

886-935667922; yhc1228@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 25, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2033
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)