Early Gastric Cancer Clinical Trial
Official title:
Early Detection of Stage I-II Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
The purpose of this study is to enable non-invasive early detection of gastric cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage gastric cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and microbiome, will be assessed to generate this model.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 31, 2023 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age minimum 18 years - Participants must have histologically and/or cytologically confirmed stage I/II gastric cancer - Full access to the patients' clinical and pathological records - Ability to understand and the willingness to sign a written informed consent document - Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening Exclusion Criteria: - Participants must not be pregnant or breastfeeding - Participants must not have prior cancer histories or a second non-gastric malignancy - Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy - Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection - Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation - Participants with clinically important abnormalities or conditions unsuitable for blood collection - Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements or influence patient signing the written informed consent |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital | Nanjing Geneseeq Technology Inc |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under curve of the model for detecting stage I/II gastric cancer | The area under curve of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate | 2 years | |
Secondary | Sensitivity of the early detection model | The sensitivity of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate | 2 years | |
Secondary | Specificity of the early detection model | The specificity of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate | 2 years | |
Secondary | Area under curve of the early detection model at sequencing depth downsampling | The area under curve of the model at sequencing depth downsampling for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate | 2 years |
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