Esophageal CancerNCT06895551
Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection
An observational study of Esophageal Cancer, run by Singlera Genomics Inc. at 1 site in China.
Trial summary
Esophageal cancer is a highly aggressive malignancy with poor prognosis, ranking as the sixth leading cause of cancer-related deaths worldwide, particularly prevalent in regions such as East Asia and East Africa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 1,069 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 20 Feb 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 patients with malignant lesions, including esophageal cancer and HGIN, and 500 patients with benign lesions, including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, and benign esophageal/gastric lesions
Who may be able to join
- Age 18 years or older, regardless of gender.
- Willing to undergo gastroscopy or able to provide postoperative esophageal biopsy pathological results.
- Newly diagnosed esophageal cancer patients (Stage I-IV) who have not undergone surgery, radiotherapy, chemotherapy, targeted therapy, or other tumor-related interventions prior to blood collection (for patients requiring neoadjuvant therapy, blood collection should be performed 1-2 days before neoadjuvant therapy; for patients not requiring neoadjuvant therapy, blood collection should be performed 1-2 days before surgery).
Who cannot join
- History of digestive system tumors, including esophageal cancer, gastric cancer, colorectal cancer, liver cancer, etc.
- History of other cancers that have not achieved clinical cure (clinical cure: no recurrence or metastasis within 5 years post-surgery).
- Systemic inflammatory response syndrome.
- Severe cardiovascular disease history (e.g., previous myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; history of congestive heart failure; myocardial infarction within the past 6 months; uncontrolled severe hypertension, etc.) and deemed unsuitable for inclusion by the investigator.
- Patients who have undergone blood transfusion or major surgical procedures such as transplantation within the past 3 months.
- Participation in other interventional clinical studies within the past 3 months, or individuals who are pregnant, breastfeeding, or have autoimmune diseases, genetic disorders, mental illnesses, etc.
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- Participation in "interventional" clinical trials and use of investigational drugs within the past 30 days.
- Other diseases deemed unsuitable for inclusion by the investigator.
- Failure to adhere to the study plan for timely blood collection.
- Blood samples that do not meet the requirements (unqualified samples include: ① clotted samples; ② hemolyzed samples; ③ insufficient sample volume; ④ samples delivered for testing more than 72 hours after collection; ⑤ incorrect sample information; ⑥ severe lipemia, with blood appearing milky; ⑦ damaged collection tubes or contaminated samples, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality
About this study
Official title: Prospective Multicenter Study on Early Esophageal Cancer Detection: Circulating Tumor DNA Methylation Biomarkers in Liquid Biopsy
Esophageal cancer is a highly aggressive malignancy with poor prognosis, ranking as the sixth leading cause of cancer-related deaths worldwide, particularly prevalent in regions such as East Asia and East Africa. This prospective multicenter study aims to develop and validate a blood-based DNA methylation model for the early detection of esophageal cancer and high-grade intraepithelial neoplasia (HGIN). The study will enroll 500 patients with malignant lesions, including esophageal cancer and HGIN, and 500 patients with benign lesions, including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, benign esophageal lesions, and benign gastric lesions. Through a comprehensive workflow involving methylation marker screening, model construction, training, and validation, we will identify and optimize methylation biomarkers for esophageal cancer detection. The performance of the methylation-based diagnostic model will be rigorously evaluated, including its sensitivity, specificity, and accuracy in distinguishing malignant from benign lesions. This study has the potential to establish a non-invasive, blood-based diagnostic tool for early esophageal cancer detection, which could significantly improve patient outcomes by enabling timely intervention and treatment. The results will contribute to advancing precision medicine in oncology and provide a foundation for future large-scale clinical applications.
- Conditions
- Esophageal Cancer
- Keywords
- ctDNA methylation, early detection
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group (malignant lesions) | Including esophageal cancer and high-grade intraepithelial neoplasia (HGIN). | |
| Control group (benign lesions) | Including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, benign esophageal lesions, and benign gastric lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Methylation Biomarker Panel
Evaluate the sensitivity, specificity, and area under the curve (AUC) of the blood-based DNA methylation model in distinguishing esophageal cancer and high-grade intraepithelial neoplasia (HGIN) from benign lesions (including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, and benign esophageal/gastric lesions).
Measured: assessed up to 36 months
Secondary outcomes (1)
Model Performance in Subgroups and correlation with Clinical Parameters
Assess the diagnostic performance of the methylation model across different subgroups, including early-stage esophageal cancer, advanced-stage esophageal cancer, and HGIN. Investigate the relationship between methylation levels and clinical parameters, including tumor stage (TNM I/II/III/IV), tumor differentiation grade (high/medium/low), age and gender (male/female) etc.
Measured: assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Sep 2022
- Primary completion1 May 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,069 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895551
- Sponsor's protocol ID
- EsoMeth
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study on Early Esophageal Cancer Detection: Circulating Tumor DNA Methylation Biomarkers in Liquid Biopsy
- ClinicalTrials.gov ID
- NCT06895551
- Acronym / sponsor ID
- EsoMeth
- Conditions
- Esophageal Cancer
- Keywords
- ctDNA methylation, early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,069 participants (actual)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 26 Mar 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 cancer is a highly aggressive malignancy with poor prognosis, ranking as the sixth leading cause of cancer-related deaths worldwide, particularly prevalent in regions such as East Asia and East Africa. This prospective multicenter study aims to develop and validate a blood-based DNA methylation model for the early detection of esophageal cancer and high-grade intraepithelial neoplasia (HGIN). The study will enroll 500 patients with malignant lesions, including esophageal cancer and HGIN, and 500 patients with benign lesions, including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, benign esophageal lesions, and benign gastric lesions. Through a comprehensive workflow involving methylation marker screening, model construction, training, and validation, we will identify and optimize methylation biomarkers for esophageal cancer detection. The performance of the methylation-based diagnostic model will be rigorously evaluated, including its sensitivity, specificity, and accuracy in distinguishing malignant from benign lesions. This study has the potential to establish a non-invasive, blood-based diagnostic tool for early esophageal cancer detection, which could significantly improve patient outcomes by enabling timely intervention and treatment. The results will contribute to advancing precision medicine in oncology and provide a foundation for future large-scale clinical applications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (malignant lesions) | – | –Including esophageal cancer and high-grade intraepithelial neoplasia (HGIN). |
| Control group (benign lesions) | – | –Including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, benign esophageal lesions, and benign gastric lesions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients with malignant lesions, including esophageal cancer and HGIN, and 500 patients with benign lesions, including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, and benign esophageal/gastric lesions
Key inclusion criteria (3 listed)
- Age 18 years or older, regardless of gender.
- Willing to undergo gastroscopy or able to provide postoperative esophageal biopsy pathological results.
- Newly diagnosed esophageal cancer patients (Stage I-IV) who have not undergone surgery, radiotherapy, chemotherapy, targeted therapy, or other tumor-related interventions prior to blood collection (for patients requiring neoadjuvant therapy, blood collection should be performed 1-2 days before neoadjuvant therapy; for patients not requiring neoadjuvant therapy, blood collection should be performed 1-2 days before surgery).
Key exclusion criteria (10 listed)
- History of digestive system tumors, including esophageal cancer, gastric cancer, colorectal cancer, liver cancer, etc.
- History of other cancers that have not achieved clinical cure (clinical cure: no recurrence or metastasis within 5 years post-surgery).
- Systemic inflammatory response syndrome.
- Severe cardiovascular disease history (e.g., previous myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; history of congestive heart failure; myocardial infarction within the past 6 months; uncontrolled severe hypertension, etc.) and deemed unsuitable for inclusion by the investigator.
- Patients who have undergone blood transfusion or major surgical procedures such as transplantation within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Methylation Biomarker Panel
Time frame: assessed up to 36 months
Evaluate the sensitivity, specificity, and area under the curve (AUC) of the blood-based DNA methylation model in distinguishing esophageal cancer and high-grade intraepithelial neoplasia (HGIN) from benign lesions (including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, and benign esophageal/gastric lesions).
1 secondary outcome
Model Performance in Subgroups and correlation with Clinical Parameters
Time frame: assessed up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Esophageal Cancer, run by Singlera Genomics Inc. at 1 site in China.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 1 Apr 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Methylation Biomarker Panel (time frame: assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.