Status:
COMPLETED
Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection
Lead Sponsor:
Singlera Genomics Inc.
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- 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.).
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
1069 Patients enrolled
Trial Details
Trial ID
NCT06895551
Start Date
September 1 2022
End Date
February 20 2025
Last Update
April 1 2025
Active Locations (1)
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1
Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, China