Novel biomarkers for early detection of gastric cancer

Table 3 Clinical trials of blood-based biofluid biomarkers for gastric cancer detection

Clinical trials	Type of trial	Phase	Results	Participants (estimated)	Assay	Comments
ctDNA
NCT05027347	Cohort	NA	Recruiting	200	Ultradeep massive parallel sequencing assay	Development of a protocol for detection of ctDNA in plasma of patients with early stages of GC
NCT04511559	Cohort	NA	Not yet recruiting	540	ctDNA methylation sequencing	The correlation between the plasma ctDNA methylation status and the diagnosis of patients with early GC
NCT05208372	Case-control	NA	Recruiting	200	CTC and ctDNA test	Investigation of the value of CTCs and ctDNA in the diagnosis of metastasis of GC in peritoneal flushing fluid and blood
NCT04665687	Cohort	NA	Recruiting	1730	Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing	Identification whether tumor’s molecular profiling based on blood could be used for diagnosis of EGC and precancerous gastric adenoma
NCT05029869	Cohort	NA	Recruiting	100	NGS technologies	Study aims to evaluate the use of NGS to detect ctDNA in GC patients after gastrectomy
NCT05224596	Case-control	NA	Recruiting	498	Blood draw and blood-based biomarkers analyses	Multi-omics 498 study aimed at detecting GC by combined assays for serum protein markers, deep sequencing of cfDNA, ctDNA mutation and RNA
miRNAs
NCT04329299	Cohort	NA	Completed	6862	Blood-based biomarkers analyses	Validation of the predictive value of various blood biomarkers, such as miRNA
lncRNAs
NCT05397548	Cohort	NA	Recruiting	700	RT-PCR	Study to investigate the predictive value of circulating exosomal lncRNA-GC1 for early-detection and monitoring progression of GC
Methylation
NCT04511559	Cohort	NA	Not yet recruiting	540	ctDNA methylation sequencing	Methylation analysis of ct DNA in early diagnosis in patients with GC
NCT03076567	Observational	NA	Completed	440	NA	Discovery and validation of plasma DNA methylation biomarker for detection of GC
NCT05336058	Cohort	NA	Recruiting	1240	Multi-target PCR	Exploration of the clinical performance of polygene methylation in the adjunctive diagnosis of GC
NCT04253106	Non-randomized	NA	Recruiting	10	NGS	Activating methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with DGC
Multi-omics
NCT04947995	Case-control	NA	Recruiting	450	ctDNA multi-omics test	Exploration of a blood-based multi-omics assay and computational model for early detection of GC
NCT05347524	Observational	NA	Recruiting	384	Blood draw and blood-based biomarkers analyses	Detection of peritoneal metastasis of GC by combined assays for methylation of cfDNA and other blood-based biomarkers

GC: Gastric cancer; NGS: Next generation sequencing; PCR: Polymerase chain reaction; DGC: Diffuse gastric cancer; ctDNA: Circulating tumor DNA; cfDNA: Cell-free DNA; miRNA: MicroRNA; lncRNA: Long non-coding RNA; NA: Not applicable; lncRNA-GC1: Gastric cancer-associated lncRNA1.