Clinical Trials Directory

Trials / Completed

CompletedNCT02159339

DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma

A Cohort Study on Prediction of Metastasis of Gastric Carcinoma by DNA Methylation Biomarkers

Status
Completed
Phase
Study type
Observational
Enrollment
198 (actual)
Sponsor
Peking University Cancer Hospital & Institute · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In previous multi-center study, we have found that the prevalence of GDNF family receptor alpha 1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and coordinately associated with GC metastasis and the patients' overall survival throughout discovery and testing cohorts in China, Japan and Korea. The present cohort study is to investigate whether methylation of those genes can predict the metastasis and prognosis of GC.

Detailed description

Background: Metastasis is the leading cause of death for gastric carcinoma (GC). Currently, GC prognosis is primarily determined based on the clinical data and pathological stages of patients at the time of diagnosis and treatment. However, successful management of GC patients is still hampered by lack of highly sensitive and specific biomarkers capable of predicting prognosis and likelihood of metastasis. GFRA1 hypomethylation along with SRF and ZNF382 hypermethylation were found to be potential synergistic biomarkers for the prediction of GC metastasis in our previous multi-center study. In addition, p16 and E-cadherin were also correlated with GC metastasis in Chinese cohort. To investigate the predictive value of those genes' methylation on metastasis potential in GC, we carried out the prospective cohort study. Methods: 198 early stage GC patients without lymph node or distal metastasis were included in the present study. Baseline information of E-cadherin, GFRA1, p16, SRF and ZNF382 methylation status of the GC from 191 cases was obtained by MethyLight. The follow-up examination was carried out in a double-blind study with a 6-month interval. The association between gene methylation and metastasis of GC was analyzed with SPSS16.0 software. All P-values were two-sided.

Conditions

Timeline

Start date
2012-12-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2014-06-09
Last updated
2015-06-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02159339. Inclusion in this directory is not an endorsement.