Forecasting Occult liveR Metastasis Using an Exosomal Signature for Intelligent Guided Hepatic Targeting

NCT07224802 | Completed

• 1 other identifier: 19288/FORESIGHT
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

Early liver metastasis (Early-LiM) is the most significant prognostic factor in pancreatic ductal adenocarcinoma (PDAC) and is thought to originate from occult micrometastases present at the time of surgery. Reliable preoperative detection of such lesions remains an unmet clinical need. 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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic ductal adenocarcinoma; exosomal miRNA; early liver metastasis; liquid biopsy; exosome

Outcome Measures

Primary Outcomes (1)

• Specificity

  True Negative Rate: probability of a negative test result conditioned on absence of early liver metastasis

  Through study completion, an average of 3 year

Secondary Outcomes (2)

• Sensitivity

  Through study completion, an average of 3 year

• Area Under the Receiver Operating Characteristic Curve (AUC)

  Through study completion, an average of 3 year

Study Arms (6)

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).

Diagnostic Test: EXELiM assay (qRT-PCR validation)

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).

Diagnostic Test: EXELiM assay (qRT-PCR validation)

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).

Diagnostic Test: EXELiM assay (qRT-PCR validation)

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).

Diagnostic Test: EXELiM assay (qRT-PCR validation)

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.

Diagnostic Test: EXELiM small RNA sequencing

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.

Diagnostic Test: EXELiM small RNA sequencing

Interventions

EXELiM assay (qRT-PCR validation) DIAGNOSTIC_TEST

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 with Occult Liver Metastasis; Training Cohort - PDAC without Occult Liver Metastasis; Validation Cohort - PDAC with Occult Liver Metastasis; Validation Cohort - PDAC without Occult Liver Metastasis

EXELiM small RNA sequencing DIAGNOSTIC_TEST

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 with Occult Liver Metastasis; Discovery Cohort - PDAC without Occult Liver Metastasis

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

Patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC) who have undergone curative-intent pancreatectomy with available preoperative plasma samples.

You may qualify if:

• Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
• Undergoing curative-intent pancreatectomy
• Availability of preoperative plasma samples
• Complete clinical and follow-up data
• Written informed consent obtained

You may not qualify if:

• Synchronous or secondary malignancies
• Non-adenocarcinoma histology
• Lack of informed consent
• Incomplete plasma sample data

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91016, United States

Location

Related Publications (15)

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Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: June 21, 2024
• Primary Completion: January 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)