Clinical trial · Observational
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
NCT05668910CI-TRIAL-00062959unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| whole genomic methylation and fragmentation profile analysis of cfDNA | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- malignant group
- description
- patients diagnosed with high grade Intraepithelial neoplasia or GC (\> 50% of patients in stage I and II)
- interventionNames
- Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
- label
- non-malignant group
- description
- healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases
- interventionNames
- Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
Primary outcomes (2)
- measure
- The performance of each single feature and the ensemble model with integrated features for early GC detection
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Complete clinical info; 2. Patients self-agree to join the study and with signed patient consent and good compliance. The specific inclusion criteria for subjects to be included in the malignant group: 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: 1. Diagnosed previously with any kind of malignant tumor; 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.
References
Publications (1)
- DERIVEDHan 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 37728978