Clinical trial · Observational
Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma
SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
- 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)
Esophageal squamous cell carcinoma (ESCC) remains a highly lethal cancer worldwide, largely due to late diagnosis. Current screening methods such as upper endoscopy are invasive, operator-dependent, and limited in their ability to detect early-stage lesions. To address this clinical need, the SYNERGY study seeks to develop a non-invasive, blood-based biomarker assay that integrates cell-free microRNAs (cf-miRNAs) and exosomal microRNAs (exo-miRNAs) to detect ESCC at an early and potentially curable stage. This multicenter translational study includes discovery, training, and validation phases using preoperative plasma or serum samples. By combining the tumor specificity of exosomal miRNAs with the systemic sensitivity of cf-miRNAs, SYNERGY aims to construct a robust diagnostic model with high sensitivity and specificity for early ESCC detection.
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 |
|---|---|---|---|
| ESCC | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCR-based validation (SYNERGY assay) | Diagnostic Test | — | UNRESOLVED |
| RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) | Diagnostic Test | — | UNRESOLVED |
| Small RNA sequencing of exo- and cf-miRNAs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Discovery cohort (ESCC)
- description
- Patients with ESCC
- interventionNames
- Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs
- label
- Discovery cohort (NDC)
- description
- Non-Disease Control
- interventionNames
- Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs
- label
- Training cohort (ESCC)
- description
- Patients with ESCC
- interventionNames
- Diagnostic Test: PCR-based validation (SYNERGY assay)
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults age 18 to 90 years * Histologically confirmed esophageal squamous cell carcinoma * No prior systemic therapy before sample collection * For control groups: absence of malignant disease Exclusion Criteria: * Lack of informed consent * Inadequate sample volume or RNA quality * Prior cancer within 5 years (except localized cancers) * Active systemic inflammation that may alter circulating RNA profiles
References
Publications (11)
- BACKGROUNDMao Y, Fu Z, Zhang Y, Dong L, Zhang Y, Zhang Q, Li X, Wang C. A six-microRNA risk score model predicts prognosis in esophageal squamous cell carcinoma. J Cell Physiol. 2019 May;234(5):6810-6819. doi: 10.1002/jcp.27429. Epub 2018 Nov 1. PMID 30387125
- BACKGROUNDLi T, Sun G, Ye H, Song C, Shen Y, Cheng Y, Zou Y, Fang Z, Shi J, Wang K, Dai L, Wang P. ESCCPred: a machine learning model for diagnostic prediction of early esophageal squamous cell carcinoma using autoantibody profiles. Br J Cancer. 2024 Sep;131(5):883-894. doi: 10.1038/s41416-024-02781-w. Epub 2024 Jul 2. PMID 38956246
- BACKGROUNDLi K, Lin Y, Zhou Y, Xiong X, Wang L, Li J, Zhou F, Guo Y, Chen S, Chen Y, Tang H, Qiu X, Cai S, Zhang D, Bremer E, Jim Yeung SC, Zhang H. Salivary Extracellular MicroRNAs for Early Detection and Prognostication of Esophageal Cancer: A Clinical Study. Gastroenterology. 2023 Oct;165(4):932-945.e9. doi: 10.1053/j.gastro.2023.06.021. Epub 2023 Jul 1. PMID 37399999
- BACKGROUNDMiyoshi J, Zhu Z, Luo A, Toden S, Zhou X, Izumi D, Kanda M, Takayama T, Parker IM, Wang M, Gao F, Zaidi AH, Baba H, Kodera Y, Cui Y, Wang X, Liu Z, Goel A. A microRNA-based liquid biopsy signature for the early detection of esophageal squamous cell carcinoma: a retrospective, prospective and multicenter study. Mol Cancer. 2022 Feb 11;21(1):44. doi: 10.1186/s12943-022-01507-x. PMID 35148754
- BACKGROUNDChen J, Zheng Y, Wang Z, Gao Q, Hao K, Chen X, Ke N, Lv X, Weng J, Zhong Y, Huang Z, Fu M, Zhao L, Lin F, Mi H, Tang H, Yu C, Huang Y. Development a glycosylated extracellular vesicle-derived miRNA Signature for early detection of esophageal squamous cell carcinoma. BMC Med. 2025 Jan 23;23(1):39. doi: 10.1186/s12916-025-03871-z. PMID 39849483
- BACKGROUNDCodipilly DC, Wang KK. Squamous Cell Carcinoma of the Esophagus. Gastroenterol Clin North Am. 2022 Sep;51(3):457-484. doi: 10.1016/j.gtc.2022.06.005. Epub 2022 Aug 29.