Esophageal Cancer
Conditions
Interventions
Gold Standard:The gold standard for diagnosis of "malignant tumor" is the pathological diagnosis of biopsy or operation.
Index test:cfDNA methylation, cfDNA fragmentation
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for All Participants: 1) Able to provide a written informed consent. 2) Aged 18-75 years, gender unlimited. Inclusion Criteria for Cancer Arm Participants: 1) Diagnosed as esophageal cancer within 30 days prior to study screening. 2) Have received or are undergoing none of selective and systmatic treatment before blood drawing. 3) ECOG 0-1. 4) Able to provide the primary lesion with grade ?-? after surgery in participants collecting both tumor and paracancerous tissue. Inclusion Criteria for Precancerous Arm Participants: 1) Diagnosed as Barrett's esophagus, low-grade squamous intraepithelial neoplasia or high-grade squamous intraepithelial neoplasia based on imaging and pathology within 90 days before blood drawing. 2) Have accepted or are undergoing none treatments before blood drawing. Inclusion Criteria for high-risk healthy Arm Participants: 1) No cancer related symptoms before blood drawing. 2) No clinically significant findings via abdominal color Doppler ultrasound. 3) Age>40 years old (40-75 years old), and combined with one of the high risk factors of esophageal cancer, including family history of esophageal cancer, regional (in or from high incidence areas), heavy smoking and drinking, excessive eating.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for All Participants: 1) Failed to follow the study procedure. 2) During pregnancy or lactation. 3) Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. 4) Recipient of blood transfusion within 7 days prior to study blood drawing. Exclusion Criteria for Cancer Arm Participants: 1) Multiple primary tumors or mergering with other tumors. 2) Esophageal cancer was not confirmed by imaging or pathology, or diagnosed as benign disease according to histology, or unable to confirm malignant or benign within 30 days prior to study screening. 3) Only able to provide the metastatic lesion with grade ? after surgery in participants collecting both tumor and paracancerous tissue. Exclusion Criteria for Precancerous Arm Participants: 1) A history of malignant tumors. 2) Barrett's esophagus, low-grade squamous intraepithelial neoplasia or high-grade squamous intraepithelial neoplasia were not confirmed by imaging or pathology, or unable to confirm malignant or benign within 30 days prior to study screening. Exclusion Criteria for high-risk healthy Arm Participants: 1) Participated in anti-cancer treatment within the past 3 years or undergoing anti-caner treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cfDNA methylation;cfDNA fragmentation;Sensitivity;Specificity;Positive predicative value; | — |
Countries
China
Contacts
Public ContactWenya Li
The First Hospital of China Medical University
Outcome results
None listed