Clinical trial · Observational
Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers
Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastric cancer (GC) is a leading cause of cancer-related death worldwide. Even in patients undergoing curative surgery for non-metastatic disease, postoperative recurrence frequently occurs due to undetected minimal residual disease (MRD). This study aims to establish a highly sensitive and specific liquid biopsy assay using exosomal microRNAs (exo-miRNAs) to detect MRD and predict distant metastasis before clinical recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENLIGHT Assay | Diagnostic Test | — | UNRESOLVED |
| small RNA-seq or array | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Discovery Cohort - Distant Metastasis Positive
- description
- Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing.
- interventionNames
- Diagnostic Test: small RNA-seq or array
- label
- Discovery Cohort - Distant Metastasis Negative
- description
- Patients without postoperative metastasis; used as reference controls in discovery phase.
- interventionNames
- Diagnostic Test: small RNA-seq or array
- label
- Training Cohort - MRD Positive (High Risk)
- description
- Patients exhibiting postoperative recurrence within 12 months.
- interventionNames
- Diagnostic Test: ENLIGHT Assay
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma. * 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: * Insufficient plasma volume or RNA quality for exosomal extraction. * Presence of synchronous or metachronous malignancies. * Received neoadjuvant chemotherapy without postoperative follow-up. * Lack of consent or incomplete clinicopathologic data.
References
Publications (0)
Data not yet available