Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
NCT ID: NCT05668910
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
360 participants
OBSERVATIONAL
2022-09-01
2024-03-31
Brief Summary
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Detailed Description
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This study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfDNA for GC early detection. Specifically, blood samples will be prospectively collected before gastroscopy. Cases and controls will be randomly divided into a training and a testing dataset at a ratio of 2:1. Plasma cfDNA will be isolated and extracted, followed with a bisulfite-free low-depth whole methylome sequencing. A multi-dimensional model named THorough Epigenetic Marker Integration Solution (THEMIS) including methylation, fragmentation, and chromosomal copy number alternation will be constructed in the training dataset. The performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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malignant group
patients diagnosed with high grade Intraepithelial neoplasia or GC (\> 50% of patients in stage I and II)
whole genomic methylation and fragmentation profile analysis of cfDNA
The assay for gastric cancer early detection will be built based on low-depth methylone sequencing followed with a multi-dimensional model construction with analysing several features such as methylation, fragmentation, and chromosomal copy number alternation.
non-malignant group
healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases
whole genomic methylation and fragmentation profile analysis of cfDNA
The assay for gastric cancer early detection will be built based on low-depth methylone sequencing followed with a multi-dimensional model construction with analysing several features such as methylation, fragmentation, and chromosomal copy number alternation.
Interventions
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whole genomic methylation and fragmentation profile analysis of cfDNA
The assay for gastric cancer early detection will be built based on low-depth methylone sequencing followed with a multi-dimensional model construction with analysing several features such as methylation, fragmentation, and chromosomal copy number alternation.
Eligibility Criteria
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Inclusion Criteria
2. Patients self-agree to join the study and with signed patient consent and good compliance.
1. According to the definition of AJCC's 8th Edition Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology and with pathological stages of stage I-IV, including patients with esophageal gastric junction adenocarcinoma (EGJ);
2. Has not previously received any local or systematic anti-tumor treatment.
Exclusion Criteria
2. Have received total or partial gastrectomy;
3. Have received bone marrow or organ transplantation;
4. Have received blood transfusion in the past 6 months;
5. Incomplete clinical info or unqualified to participate in the study.
ALL
Yes
Sponsors
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The First Affiliated Hospital of Air Force Medicial University
OTHER
GeneCast Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Gang Ji
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
Locations
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The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Gang Ji
Role: primary
References
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Han Y, Wei J, Wang W, Gao R, Shen N, Song X, Ni Y, Li Y, Xu LD, Chen W, Li X. Multidimensional Analysis of a Cell-Free DNA Whole Methylome Sequencing Assay for Early Detection of Gastric Cancer: Protocol for an Observational Case-Control Study. JMIR Res Protoc. 2023 Sep 20;12:e48247. doi: 10.2196/48247.
Other Identifiers
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D-P200110-MCCGW-HP-7-GC
Identifier Type: -
Identifier Source: org_study_id