Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
Development and Validation of a Blood-based Assay for Gastric Cancer Early Detection Using Multi-dimensional Analysis of Cell Free DNA Whole Methylome Sequencing-Protocol for an Observational, Case-control Study
1 other identifier
observational
360
1 country
1
Brief Summary
To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedDecember 30, 2022
November 1, 2022
1.6 years
December 12, 2022
December 25, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
The performance of each single feature and the ensemble model with integrated features for early GC detection
The efficacy of each single feature-based model and the ensemble model comparing with pathologic diagnostic results, the gold standard, and gastroscope diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
18 months
The performance of each single feature and the ensemble model with integrated features for early GC detection in each clinical stage
The efficacy of each single feature-based model and the ensemble model comparing with pathologic diagnostic results, the gold standard, and gastroscope diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
18 months
Secondary Outcomes (1)
The performance of the ensemble model in combination of possible GC related biomarkers such as PG, G17, and/or Hp levels for early GC detection
18 months
Study Arms (2)
malignant group
patients diagnosed with high grade Intraepithelial neoplasia or GC (\> 50% of patients in stage I and II)
non-malignant group
healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases
Interventions
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
This study will enroll about 360 individuals who receive gastroscopy in The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, Shaanxi province, China. Two groups will be formed based on gastroscopy results, malignant group and non-malignant group. The malignant group includes patients diagnosed with high grade Intraepithelial neoplasia or GC (\> 50% of patients in stage I and II) while the non-malignant group contains healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.
You may qualify if:
- Complete clinical info;
- Patients self-agree to join the study and with signed patient consent and good compliance.
- 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);
- Has not previously received any local or systematic anti-tumor treatment.
You may not qualify if:
- Diagnosed previously with any kind of malignant tumor;
- Have received total or partial gastrectomy;
- Have received bone marrow or organ transplantation;
- Have received blood transfusion in the past 6 months;
- Incomplete clinical info or unqualified to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Xi'an, Shaanxi, China
Related Publications (1)
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.
PMID: 37728978DERIVED
Biospecimen
peripheral blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Ji
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2022
First Posted
December 30, 2022
Study Start
September 1, 2022
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
December 30, 2022
Record last verified: 2022-11