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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05269056
Other study ID # IRB-2021-295
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date May 31, 2023

Study information

Verified date May 2022
Source Zhejiang Cancer Hospital
Contact Pengfei Yu, MD, PhD
Phone 86-571-88128031
Email ypfzmu@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


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-free DNA analysis in cancer early detection, by moving away from cell-free DNA methylome toward an integrative approach that enables the simultaneous assessment of multimodal cell-free DNA features. Integration of liquid biopsy-based cancer early detection into the clinic requires optimization of detection techniques, large-scale studies and prospective clinical validation. In the early detection of gastric cancer, the top research priorities are to identify relevant target features and to improve the sensitivity and specificity of detection. This large-scale early detection study will randomly enroll 200 stage I/II pathologically diagnosed gastric patients and 100 age- and sex-matched healthy individuals upon providing written informed consent. Plasma samples will be collected and extracted cell-free DNA will be subjected to whole genome sequencing. We aimed to incorporate genome-wide copy number variations, cell-free DNA fragmentomics, and microbiome features into the development of a multimodal biomarker-based prediction model.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital Nanjing Geneseeq Technology Inc

Country where clinical trial is conducted

China, 

Outcome

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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