Recruiting

Blood-based Biomarker

Sponsor:

City of Hope Medical Center

Code:

NCT07266363

Conditions

ESCC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Small RNA sequencing of exo- and cf-miRNAs

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

PCR-based validation (SYNERGY assay)

Study Details

Brief 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.

Conditions

ESCC

Study ID

NCT07266363

Start date

Jan 15, 2025

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Discovery cohort (ESCC)

Patients with ESCC

Discovery cohort (NDC)

Non-Disease Control

Training cohort (ESCC)

Patients with ESCC

Training cohort (NDC)

Non-Disease Control

Testing cohort (ESCC)

Patients with ESCC

Testing cohort (NDC)

Non-Disease Control

Interventions

Small RNA sequencing of exo- and cf-miRNAs

Identification of differentially expressed cf-miRNAs

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

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

PCR-based validation (SYNERGY assay)

PCR-based validation of the SYNERGY miRNA panel

Primary outcome measure

  • Sensitivity [ Time Frame: At study completion, an average of one year ]

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

Locations

City of Hope Medical Center

Recruiting

Monrovia, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Exosomal miRNAs
  • Cell-free miRNAs
  • Esophageal squamous cell carcinoma
  • Liquid biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.