Exosomal miRNA Liquid Biopsy for Early Liver Metastasis Detection in Pancreatic Cancer
NCT ID: NCT07224802
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-06-21
2026-06-18
Brief Summary
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The EXELiM study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to accurately identify PDAC patients at high risk of occult liver metastasis before surgery. By integrating machine learning with multi-institutional plasma exosome profiling, this study seeks to enable biology-driven patient stratification and guide treatment sequencing toward precision oncology.
Detailed Description
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Emerging evidence indicates that pancreatic tumors release exosomes that modulate the liver microenvironment, establishing a premetastatic niche that facilitates early colonization. We hypothesize that circulating exosomal microRNAs reflect these biological processes and can serve as non-invasive biomarkers for detecting occult liver metastasis.
In this multi-center observational study, preoperative plasma-derived exosomes from PDAC patients are analyzed using next-generation small RNA sequencing and validated by RT-qPCR. A machine learning model is employed to integrate exo-miRNA expression profiles and clinical variables, yielding a predictive score for early liver metastasis risk.
The study evaluates the diagnostic accuracy, prognostic utility, and clinical benefit of the exo-miRNA panel compared to conventional biomarkers such as CA19-9.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Training Cohort - PDAC with Occult Liver Metastasis
Patients with PDAC who were found to have occult liver metastases at the time of or shortly after curative-intent pancreatectomy (within 6 months post-surgery), in the first cohort (training set).
EXELiM assay (qRT-PCR validation)
Quantitative reverse-transcription PCR (qRT-PCR)-based validation assay performed on preoperative plasma samples from PDAC patients in the training and validation cohorts.
Candidate microRNAs identified by small RNA sequencing were tested using the EXELiM assay to validate their predictive accuracy for occult liver metastasis detection prior to surgery.
Training Cohort - PDAC without Occult Liver Metastasis
Patients with PDAC who did not develop liver metastasis for at least 6 months after curative-intent surgery in the first cohort (training set).
EXELiM assay (qRT-PCR validation)
Quantitative reverse-transcription PCR (qRT-PCR)-based validation assay performed on preoperative plasma samples from PDAC patients in the training and validation cohorts.
Candidate microRNAs identified by small RNA sequencing were tested using the EXELiM assay to validate their predictive accuracy for occult liver metastasis detection prior to surgery.
Validation Cohort - PDAC with Occult Liver Metastasis
Patients with PDAC who were found to have occult liver metastases (early postoperative hepatic recurrence within 6 months) in the second cohort (validation set).
EXELiM assay (qRT-PCR validation)
Quantitative reverse-transcription PCR (qRT-PCR)-based validation assay performed on preoperative plasma samples from PDAC patients in the training and validation cohorts.
Candidate microRNAs identified by small RNA sequencing were tested using the EXELiM assay to validate their predictive accuracy for occult liver metastasis detection prior to surgery.
Validation Cohort - PDAC without Occult Liver Metastasis
Patients with PDAC who did not develop liver metastasis for at least 6 months after curative-intent surgery in the second cohort (validation set).
EXELiM assay (qRT-PCR validation)
Quantitative reverse-transcription PCR (qRT-PCR)-based validation assay performed on preoperative plasma samples from PDAC patients in the training and validation cohorts.
Candidate microRNAs identified by small RNA sequencing were tested using the EXELiM assay to validate their predictive accuracy for occult liver metastasis detection prior to surgery.
Discovery Cohort - PDAC with Occult Liver Metastasis
Patients with PDAC who were found to have occult liver metastases at the time of or shortly after curative-intent pancreatectomy (within 6 months post-surgery), in the discovery cohort.
EXELiM small RNA sequencing
High-throughput small RNA sequencing performed on preoperative plasma samples from PDAC patients in the discovery cohort to identify exosome-derived microRNAs associated with occult liver metastasis or early postoperative hepatic recurrence.
Discovery Cohort - PDAC without Occult Liver Metastasis
Patients with PDAC who did not develop liver metastasis for at least 6 months after curative-intent surgery in the discovery cohort.
EXELiM small RNA sequencing
High-throughput small RNA sequencing performed on preoperative plasma samples from PDAC patients in the discovery cohort to identify exosome-derived microRNAs associated with occult liver metastasis or early postoperative hepatic recurrence.
Interventions
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EXELiM assay (qRT-PCR validation)
Quantitative reverse-transcription PCR (qRT-PCR)-based validation assay performed on preoperative plasma samples from PDAC patients in the training and validation cohorts.
Candidate microRNAs identified by small RNA sequencing were tested using the EXELiM assay to validate their predictive accuracy for occult liver metastasis detection prior to surgery.
EXELiM small RNA sequencing
High-throughput small RNA sequencing performed on preoperative plasma samples from PDAC patients in the discovery cohort to identify exosome-derived microRNAs associated with occult liver metastasis or early postoperative hepatic recurrence.
Eligibility Criteria
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Inclusion Criteria
* Undergoing curative-intent pancreatectomy
* Availability of preoperative plasma samples
* Complete clinical and follow-up data
* Written informed consent obtained
Exclusion Criteria
* Non-adenocarcinoma histology
* Lack of informed consent
* Incomplete plasma sample data
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ajay Goel, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ajay Goel, PhD
Role: primary
References
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Other Identifiers
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19288/EXELiM
Identifier Type: -
Identifier Source: org_study_id