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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

This trial accepts healthy volunteers

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 population

Patients with histologically confirmed ESCC Healthy volunteers or non-disease controls (NDC)

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Small RNA sequencing of exo- and cf-miRNAs

    Diagnostic test

    Identification of differentially expressed cf-miRNAs

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

    Diagnostic test

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

  • PCR-based validation (SYNERGY assay)

    Diagnostic test

    PCR-based validation of the SYNERGY miRNA panel

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Discovery cohort (ESCC)1 intervention
Group B: Discovery cohort (NDC)1 intervention
Group C: Training cohort (ESCC)1 intervention
Group D: Training cohort (NDC)1 intervention
Group E: Testing cohort (ESCC)1 intervention
Group F: Testing cohort (NDC)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

Comparison of Pathological Diagnosis and the SYNERGY Assay

Time frame
At study completion, an average of one year

Secondary outcomes

1

AUC

AUC of integrated cf- + exo-miRNA model

Time frame
At Study completion, an average of one year
2

Specificity

Description: Comparison of Pathological Diagnosis and the SYNERGY Assay

Time frame
Time Frame: At study completion, , an average of one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov
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