Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01814345
Status:
TERMINATED
Last Update Posted:
2017-04-27
First Post:
2013-02-27
Brief Title:
Her 2 Testing in Indian Patients With Gastric Cancer
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers
Status:
TERMINATED
Status Verified Date:
2017-04
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 cancer remains a major health issue and a leading cause of cancer death worldwide although the prevalence and mortality of the disease have gradually decreased The investigators have very few options for patients with advanced disease
The trastuzumab for Gastric Cancer ToGA trial a pivotal randomized clinical trial of patients with HER-2 positive advanced mostly metastatic gastric cancer proved the efficacy of trastuzumab anti-Her 2 therapy in combination with chemotherapy The median overall survival was significantly prolonged in the trastuzumab-containing arm 138 vs 111 months HR 074 p00046 without unexpected toxicity including cardiac events The survival benefit was most pronounced in the subgroup of high HER-2neu protein overexpression median overall survival of 16 months Only 20 of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas
Data on Indian patients is lacking Hence the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2 and 3 patients
The trastuzumab for Gastric Cancer ToGA trial a pivotal randomized clinical trial of patients with HER-2 positive advanced mostly metastatic gastric cancer proved the efficacy of trastuzumab anti-Her 2 therapy in combination with chemotherapy The median overall survival was significantly prolonged in the trastuzumab-containing arm 138 vs 111 months HR 074 p00046 without unexpected toxicity including cardiac events The survival benefit was most pronounced in the subgroup of high HER-2neu protein overexpression median overall survival of 16 months Only 20 of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas
Data on Indian patients is lacking Hence the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2 and 3 patients
Detailed Description:
1 Study Objective Aims Aim - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective
Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients Patients with 2 and 3 IHC will also have FISH done
2 Study Design Methodology
Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2 and 3 result will also have FISH done This will not affect patient management
3 Overview of Data collection DrBhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records The patient will be de-identified
4 Selection of Study Population
Inclusion Criteria
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria
If histopathology blocks were not available
5 Sample size 100 to be enrolled Patient consent waiver applied for as this does not affect patient care 6 Statistical Analysis It is an Observational study so Results will be given as age of total population
Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients Patients with 2 and 3 IHC will also have FISH done
2 Study Design Methodology
Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2 and 3 result will also have FISH done This will not affect patient management
3 Overview of Data collection DrBhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records The patient will be de-identified
4 Selection of Study Population
Inclusion Criteria
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria
If histopathology blocks were not available
5 Sample size 100 to be enrolled Patient consent waiver applied for as this does not affect patient care 6 Statistical Analysis It is an Observational study so Results will be given as age of total population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Her 2 in gastric cancer | OTHER_GRANT | Roche pharma limited | None |