Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers
NCT ID: NCT07243015
Last Updated: 2025-11-21
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
500 participants
OBSERVATIONAL
2025-01-15
2026-06-18
Brief Summary
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Detailed Description
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Exosomal microRNAs (exo-miRNAs), encapsulated within lipid bilayer vesicles, remain stable in circulation and reflect tumor-derived molecular information. This study seeks to develop and validate an exosomal miRNA-based signature capable of detecting minimal residual disease and predicting future distant metastasis after curative gastrectomy.
Study Phases
1. Discovery Phase - Comprehensive small RNA sequencing to identify miRNAs specific to distant metastasis in gastric cancer.
2. Training Phase - RT-qPCR-based quantification of candidate exo-miRNAs in postoperative plasma samples to develop an MRD signature.
3. Validation Phase - Independent cohort testing to evaluate the diagnostic performance, sensitivity, and specificity of the exosomal MRD panel.
Ultimately, the ENLIGHT assay aims to guide postoperative adjuvant chemotherapy by stratifying patients according to MRD status, enabling precision surveillance and early intervention.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Discovery Cohort - Distant Metastasis Positive
Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
small RNA-seq or array
small RNA-seq or array
Discovery Cohort - Distant Metastasis Negative
Patients without postoperative metastasis; used as reference controls in discovery phase.
small RNA-seq or array
small RNA-seq or array
Training Cohort - MRD Positive (High Risk)
Patients exhibiting postoperative recurrence within 12 months.
ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Training Cohort - MRD Negative (Low Risk)
Patients without recurrence ≥12 months postoperatively.
ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Validation Cohort - MRD Positive
Independent validation cohort with confirmed distant metastasis or MRD positivity.
ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Validation Cohort - MRD Negative
Independent validation cohort without recurrence/metastasis.
ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Interventions
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small RNA-seq or array
small RNA-seq or array
ENLIGHT Assay
RT-qPCR-based exo-miRNA quantification
Eligibility Criteria
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Inclusion Criteria
* Underwent curative-intent resection (R0).
* Availability of pre- and postoperative plasma samples.
* Documented clinical follow-up data (recurrence/metastasis status).
* Provided written informed consent.
Exclusion Criteria
* Presence of synchronous or metachronous malignancies.
* Received neoadjuvant chemotherapy without postoperative follow-up.
* Lack of consent or incomplete clinicopathologic data.
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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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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Other Identifiers
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23228/ENLIGHT
Identifier Type: -
Identifier Source: org_study_id
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