Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01927146
Status:
UNKNOWN
Last Update Posted:
2013-08-22
First Post:
2013-08-19
Brief Title:
Lauren Classifications and HER2 Status in Gastric Cancer Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Retrospective Study of Lauren Classifications and HER2 Status in Chinese Patients With Resectable Gastric Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
By literature review there is a clear trend towards a potential role for human epidermal growth factor receptor 2 HER2 as a negative prognostic factor in gastric cancer was shown but only in half of the analyses used multivariate statistics Besides For the studies in the current review that have looked at the Lauren classification in relation to HER2 a higher level of overexpression or amplification was found in the intestinal phenotype compared to the diffuse or mixed types As lauren classification was reported as an independent prognostic factor result in favored outcomes in gastric cancer GC there may probably be histologic bias exists when compare overall survival OS between HER2 statuses without controlling this confounding Similarly patients with different disease settings early stage and advanced stage resectable and metastatic affect outcomes either
In this study the investigators will retrospectively analyze HER2 status and lauren classification in 800 gastric patients who received gastrectomy in the Cancer Center of Sun Yat-Sen University between January 1996 and December 2006 with formalin-fixed and paraffin- embedded tumor tissue samples To avoid potential influence by histologic classifications and disease settings the investigators assess difference in OS between HER2 positive and HER2 negative groups in resectable Lauren classification of GCs and further evaluate the prognostic value of HER2 status according to tumor-node-metastasis TNM stages
In this study the investigators will retrospectively analyze HER2 status and lauren classification in 800 gastric patients who received gastrectomy in the Cancer Center of Sun Yat-Sen University between January 1996 and December 2006 with formalin-fixed and paraffin- embedded tumor tissue samples To avoid potential influence by histologic classifications and disease settings the investigators assess difference in OS between HER2 positive and HER2 negative groups in resectable Lauren classification of GCs and further evaluate the prognostic value of HER2 status according to tumor-node-metastasis TNM stages
Detailed Description:
Its a single site retrospective study by review of medical records and tissue testing
Eight hundred gastric adenocarcinoma patients with integrity medical record and regular survival follow up who received gastrectomy in the Cancer Center of Sun Yat-Sen University between January 1996 to December 2006 were retrospectively studied
Formalin-fixed and paraffin-embedded tumor tissue samples were retrospectively tested by human epidermal growth factor receptor 2 HER2 and Lauren classification status Her2 positive was defined as immunohistochemistry IHC 2 and fluorescence in situ hybridization FISH or IHC 3
1 After HER2 status and lauren classification identifying population used in overall survival OS comparison between Cohort 1HER2 positive and Cohort 2 negative group were carried out According to Tumor-node-metastasis TNM classification OS were to be compared between cohorts by different stages
2 Correlate histopathological characteristics with HER2 status and lauren classification were performed in the total 800 patients Meanwhile independent prognostic factors identification was to be confirmed in clinicopathological features including gender male or female age at diagnosis tumor size 5cm or 5cm location of primary tumor proximal or distal histology subtypes well moderate differentiated adenocarcinoma or poorly signet ring cell differentiated adenocarcinoma lauren classifications diffuse type or intestinal type or mixed type anemia yes or no angiolymphatic invasion yes or no the TNM staging system American Joint Committee on Cancer AJCC 7th edition and HER2 status negative and positive
Eight hundred gastric adenocarcinoma patients with integrity medical record and regular survival follow up who received gastrectomy in the Cancer Center of Sun Yat-Sen University between January 1996 to December 2006 were retrospectively studied
Formalin-fixed and paraffin-embedded tumor tissue samples were retrospectively tested by human epidermal growth factor receptor 2 HER2 and Lauren classification status Her2 positive was defined as immunohistochemistry IHC 2 and fluorescence in situ hybridization FISH or IHC 3
1 After HER2 status and lauren classification identifying population used in overall survival OS comparison between Cohort 1HER2 positive and Cohort 2 negative group were carried out According to Tumor-node-metastasis TNM classification OS were to be compared between cohorts by different stages
2 Correlate histopathological characteristics with HER2 status and lauren classification were performed in the total 800 patients Meanwhile independent prognostic factors identification was to be confirmed in clinicopathological features including gender male or female age at diagnosis tumor size 5cm or 5cm location of primary tumor proximal or distal histology subtypes well moderate differentiated adenocarcinoma or poorly signet ring cell differentiated adenocarcinoma lauren classifications diffuse type or intestinal type or mixed type anemia yes or no angiolymphatic invasion yes or no the TNM staging system American Joint Committee on Cancer AJCC 7th edition and HER2 status negative and positive
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