Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02159339
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2014-06-06
Brief Title:
DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
A Cohort Study on Prediction of Metastasis of Gastric Carcinoma by DNA Methylation Biomarkers
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1GFRA1 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 SPSS160 software All P-values were two-sided
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 SPSS160 software All P-values were two-sided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None