Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma

ConditionESCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Small RNA sequencing of exo- and cf-miRNAs
  • RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)
  • PCR-based validation (SYNERGY assay)

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators