ESCCSYNERGYNCT07266363
Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma
An observational study of ESCC, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ESCC
- What is being tested?
- Small RNA sequencing of exo- and cf-miRNAs, RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) and PCR-based validation (SYNERGY assay)
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 18 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with histologically confirmed ESCC Healthy volunteers or non-disease controls (NDC)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Monrovia, California, 91016
Ajay Goel, PhD, 626-218-3452, ajgoel@coh.org
About this study
Official title: SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
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.
Read the detailed description
Esophageal cancer is the 11th most common cancer globally and the 7th leading cause of cancer-related death, with an estimated 511,000 new cases and 445,000 deaths annually. ESCC accounts for the majority of cases worldwide. Despite advances in endoscopy and therapy, outcomes for advanced ESCC remain poor, highlighting the pressing need for sensitive, minimally invasive early detection strategies.
Exosomal miRNAs (exo-miRNAs) are selectively released by tumor cells and remain stable in circulation, enabling reliable detection of tumor-specific signals. Cell-free miRNAs (cf-miRNAs) circulate broadly and can reflect overall tumor burden, metastatic spread, and microenvironmental changes.
Previous ESCC biomarker studies were limited by small validation cohorts and reliance on tissue-based public datasets that do not fully capture circulating biomarker patterns. The SYNERGY study addresses these limitations through comprehensive discovery analysis and multi-cohort blood-based validation.
- Conditions
- ESCC
- Being tested
- Small RNA sequencing of exo- and cf-miRNAs, RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay), PCR-based validation (SYNERGY assay)
- Keywords
- Exosomal miRNAs, Cell-free miRNAs, Esophageal squamous cell carcinoma, Liquid biopsy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small RNA sequencing of exo- and cf-miRNAsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Discovery cohort (ESCC) | Patients with ESCC Receives: Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs | |
| Discovery cohort (NDC) | Non-Disease Control Receives: Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs | |
| Training cohort (ESCC) | Patients with ESCC Receives: Diagnostic Test: PCR-based validation (SYNERGY assay) | |
| Training cohort (NDC) | Non-Disease Control Receives: Diagnostic Test: PCR-based validation (SYNERGY assay) | |
| Testing cohort (ESCC) | Patients with ESCC Receives: Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) | |
| Testing cohort (NDC) | Non-Disease Control Receives: Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Comparison of Pathological Diagnosis and the SYNERGY Assay
Measured: At study completion, an average of one year
Secondary outcomes (2)
AUC
AUC of integrated cf- + exo-miRNA model
Measured: At Study completion, an average of one year
Specificity
Description: Comparison of Pathological Diagnosis and the SYNERGY Assay
Measured: Time Frame: At study completion, , an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Jan 2025
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266363
- Sponsor's protocol ID
- 23228/SYNERGY
- Acronym
- SYNERGY
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data will be made available at the time of publication through a signed data access agreement, pending approval by the investigators for proposed scientific use.
Publications
Mao 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.
PubMed 30387125Li 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.
PubMed 38956246Li 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.
PubMed 37399999Miyoshi 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.
PubMed 35148754Chen 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.
PubMed 39849483Codipilly 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.
PubMed 36153105Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Codipilly DC, Qin Y, Dawsey SM, Kisiel J, Topazian M, Ahlquist D, Iyer PG. Screening for esophageal squamous cell carcinoma: recent advances. Gastrointest Endosc. 2018 Sep;88(3):413-426. doi: 10.1016/j.gie.2018.04.2352. Epub 2018 Apr 27.
PubMed 29709526Chen J, Liu X, Zhang Z, Su R, Geng Y, Guo Y, Zhang Y, Su M. Early Diagnostic Markers for Esophageal Squamous Cell Carcinoma: Copy Number Alteration Gene Identification and cfDNA Detection. Lab Invest. 2024 Oct;104(10):102127. doi: 10.1016/j.labinv.2024.102127. Epub 2024 Aug 23.
PubMed 39182610Ma L, Dou L, Liu Y, Zhang Y, Liu X, Ng HL, Chu J, Liu Y, Li Z, Ke Y, Liu S, He S, Wang G. Development and validation of predictive models combining cell-Free DNA motifs and protein biomarkers for early detection of esophageal squamous cell carcinoma and precancerous lesion. Biomark Res. 2025 Oct 14;13(1):126. doi: 10.1186/s40364-025-00840-9.
PubMed 41088482Zheng Y, Xing W, BingWei, Liu X, Liang G, Yuan D, Yang K, Wang W, Chen D, Ma J. Detection of a novel DNA methylation marker panel for esophageal cancer diagnosis using circulating tumor DNA. BMC Cancer. 2024 Dec 26;24(1):1578. doi: 10.1186/s12885-024-13301-7.
PubMed 39725880
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07266363
- Acronym / sponsor ID
- SYNERGY / 23228/SYNERGY
- Conditions
- ESCC
- Keywords
- Exosomal miRNAs, Cell-free miRNAs, Esophageal squamous cell carcinoma, Liquid biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Esophageal cancer is the 11th most common cancer globally and the 7th leading cause of cancer-related death, with an estimated 511,000 new cases and 445,000 deaths annually. ESCC accounts for the majority of cases worldwide. Despite advances in endoscopy and therapy, outcomes for advanced ESCC remain poor, highlighting the pressing need for sensitive, minimally invasive early detection strategies.
Exosomal miRNAs (exo-miRNAs) are selectively released by tumor cells and remain stable in circulation, enabling reliable detection of tumor-specific signals. Cell-free miRNAs (cf-miRNAs) circulate broadly and can reflect overall tumor burden, metastatic spread, and microenvironmental changes.
Previous ESCC biomarker studies were limited by small validation cohorts and reliance on tissue-based public datasets that do not fully capture circulating biomarker patterns. The SYNERGY study addresses these limitations through comprehensive discovery analysis and multi-cohort blood-based validation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Discovery cohort (ESCC) | – | Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAsPatients with ESCC |
| Discovery cohort (NDC) | – | Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAsNon-Disease Control |
| Training cohort (ESCC) | – | Diagnostic Test: PCR-based validation (SYNERGY assay)Patients with ESCC |
| Training cohort (NDC) | – | Diagnostic Test: PCR-based validation (SYNERGY assay)Non-Disease Control |
| Testing cohort (ESCC) | – | Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)Patients with ESCC |
| Testing cohort (NDC) | – | Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)Non-Disease Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed ESCC Healthy volunteers or non-disease controls (NDC)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small RNA sequencing of exo- and cf-miRNAsIdentification of differentially expressed cf-miRNAs | Diagnostic test | Discovery cohort (ESCC), Discovery cohort (NDC) |
| RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier | Diagnostic test | Testing cohort (ESCC), Testing cohort (NDC) |
| PCR-based validation (SYNERGY assay)PCR-based validation of the SYNERGY miRNA panel | Diagnostic test | Training cohort (ESCC), Training cohort (NDC) |
Primary outcome
Sensitivity
Time frame: At study completion, an average of one year
Comparison of Pathological Diagnosis and the SYNERGY Assay
2 secondary outcomes
AUC
Time frame: At Study completion, an average of one year
Specificity
Time frame: Time Frame: At study completion, , an average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 30387125Mao 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.
- Background: PubMed 38956246Li 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.
- Background: PubMed 37399999Li 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.
- Background: PubMed 35148754Miyoshi 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.
- Background: PubMed 39849483Chen 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.
- Background: PubMed 36153105Codipilly 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.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 29709526Codipilly DC, Qin Y, Dawsey SM, Kisiel J, Topazian M, Ahlquist D, Iyer PG. Screening for esophageal squamous cell carcinoma: recent advances. Gastrointest Endosc. 2018 Sep;88(3):413-426. doi: 10.1016/j.gie.2018.04.2352. Epub 2018 Apr 27.
- Background: PubMed 39182610Chen J, Liu X, Zhang Z, Su R, Geng Y, Guo Y, Zhang Y, Su M. Early Diagnostic Markers for Esophageal Squamous Cell Carcinoma: Copy Number Alteration Gene Identification and cfDNA Detection. Lab Invest. 2024 Oct;104(10):102127. doi: 10.1016/j.labinv.2024.102127. Epub 2024 Aug 23.
- Background: PubMed 41088482Ma L, Dou L, Liu Y, Zhang Y, Liu X, Ng HL, Chu J, Liu Y, Li Z, Ke Y, Liu S, He S, Wang G. Development and validation of predictive models combining cell-Free DNA motifs and protein biomarkers for early detection of esophageal squamous cell carcinoma and precancerous lesion. Biomark Res. 2025 Oct 14;13(1):126. doi: 10.1186/s40364-025-00840-9.
- Background: PubMed 39725880Zheng Y, Xing W, BingWei, Liu X, Liang G, Yuan D, Yang K, Wang W, Chen D, Ma J. Detection of a novel DNA methylation marker panel for esophageal cancer diagnosis using circulating tumor DNA. BMC Cancer. 2024 Dec 26;24(1):1578. doi: 10.1186/s12885-024-13301-7.
- Individual participant dataSharing planned: No. De-identified participant data will be made available at the time of publication through a signed data access agreement, pending approval by the investigators for proposed scientific use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESCC, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajay Goel, PhD (626-218-3452, ajgoel@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: At study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07266363, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.