NCT05027347

Detection of Plasma Circulating Tumor DNA in Gastric Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Medical Center Ho Chi Minh City (UMC) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.

Detailed description

Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to \> 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.

Conditions

• Circulating Tumor DNA (ctDNA)
• Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	plasma circulating tumor DNA	A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer

Timeline

• Start date: 2021-10-10
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-08-30
• Last updated: 2022-04-28

Locations

1 site across 1 country: Vietnam