Esophageal cancer
Conditions
Interventions
Gold Standard:Esophageal endoscopy /Gastric endoscopy in addition with pathological diagnosis
Index test:The auxiliary diagnosis of esophageal cancer based on NGS technology and the multilocus qPCR-based assay targeting ctDNA methylation for auxiliary diagnosis of esophageal cancer
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Over the age of 18, gender unlimited; (2) Those who can receive gastroscopy or provide pathological examination results of postoperative esophageal biopsy; (3) Newly diagnosed patients with esophageal cancer (stage I-IV) who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related interventions before blood collection (for patients requiring neoadjuvant therapy, blood collection was performed 1-2 days before neoadjuvant therapy;Blood samples were taken 1-2 days before surgical treatment for patients who did not receive neoadjuvant therapy).
Exclusion criteria
Exclusion criteria: (1) Previous digestive system tumors, including esophageal cancer, stomach cancer, colorectal cancer, liver cancer, etc.; (2) have a history of other cancers and have not achieved clinical cure (clinical cure: no recurrence and metastasis 5 years after surgery); (3) systemic inflammatory response syndrome; (4) History of severe cardiovascular disease (such as previous history of myocardial infarction, coronary artery bypass grafting, or coronary stent implantation;History of congestive heart failure;Myocardial infarction within 6 months, uncontrolled severe hypertension, etc.) and were deemed unsuitable for inclusion by the investigators; (5) Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months (6) Participate in other interventional clinical researchers, pregnant or lactating women, or patients with autoimmune diseases, genetic diseases, mental disorders, etc., within 3 months. (7) have participated in an "interventional" clinical trial and taken the experimental drug within the past 30 days; (8) Patients with other diseases deemed unsuitable for inclusion by the researcher; (9) Failing to follow the test plan to collect blood on time; (10) The blood samples failed to meet the requirements (unqualified samples include ? sample clots;? Sample hemolysis;?Insufficient sample;?Sample delivery time exceeds 72 hours;?Error of sample information;? serious fat blood, blood looks like milk;?Sampling vessel damage, sample contamination, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value;Negative predictive value; | — |
Countries
China
Contacts
Public ContactYong li
National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed