CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 600 target
Drug / intervention
Small RNA sequencing of exo- and cf-miRNAs +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07266363
NCT07266363N/ARecruitingOn TrackUpdated 6mo ago

SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma

City of Hope Medical Center·observational·Posted Dec 5, 2025·Updated Dec 5, 2025

In Brief

An observational study evaluating Small RNA sequencing of exo- and cf-miRNAs, RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay), and 1 other intervention for ESCC. Currently recruiting, targeting 600 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsESCC
CountriesUnited States
Collaborators--

Timeline

N/ARecruitingOverdue
20252026
First PostedDec 5, 2025
Enrollment StartJan 15, 2025
Primary CompletionJun 18, 2026
TodayJul 1, 2026
Enrollment to primary: 1.4 yearsPosted 7 months ago

Interventions

Small RNA sequencing of exo- and cf-miRNAsother

Identification of differentially expressed cf-miRNAs

RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)other

RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier

PCR-based validation (SYNERGY assay)other

PCR-based validation of the SYNERGY miRNA panel