Status:
UNKNOWN
Early Detection of Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborating Sponsors:
Nanjing Geneseeq Technology Inc.
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
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 D...
Detailed Description
Improvement in the specificity of early cancer detection reduces financial and mental burdens from unnecessary screenings. Advances in liquid biopsy approaches have expanded the clinical scope of cell...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05269056
Start Date
September 1 2021
End Date
May 31 2023
Last Update
June 2 2022
Active Locations (1)
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1
Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences
Hangzhou, Zhejiang, China, 310022