Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06895551
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older, regardless of gender.
2. Willing to undergo gastroscopy or able to provide postoperative esophageal biopsy pathological results.
3. 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 Criteria:
1. History of digestive system tumors, including esophageal cancer, gastric cancer, colorectal cancer, liver cancer, etc.
2. History of other cancers that have not achieved clinical cure (clinical cure: no recurrence or metastasis within 5 years post-surgery).
3. Systemic inflammatory response syndrome.
4. 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.
5. Patients who have undergone blood transfusion or major surgical procedures such as transplantation within the past 3 months.
6. 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.
7. Participation in "interventional" clinical trials and use of investigational drugs within the past 30 days.
8. Other diseases deemed unsuitable for inclusion by the investigator.
9. Failure to adhere to the study plan for timely blood collection.
10. 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.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06895551
Study Brief:
Protocol Section:
NCT06895551