| CTRI Number |
CTRI/2024/07/070266 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the expression of HER2 immunohistochemistry in gastric cancer |
|
Scientific Title of Study
|
The expression of HER2 low in gastric and gastroesophageal junction adenocarcinoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Prasad Shah |
| Designation |
Post graduate resident |
| Affiliation |
G B Pant institute of post graduate medical education and research |
| Address |
Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
8130809433 |
| Fax |
|
| Email |
rprasadshah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puja Sakhuja |
| Designation |
Director Professor and Head |
| Affiliation |
G B Pant institute of post graduate medical education and research |
| Address |
Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
9718599073 |
| Fax |
|
| Email |
pujasak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Sakhuja |
| Designation |
Director Professor and Head |
| Affiliation |
G B Pant institute of post graduate medical education and research |
| Address |
Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
9718599073 |
| Fax |
|
| Email |
pujasak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
G B Pant institute of post graduate medical education and research |
| Address |
Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Prasad Shah |
G B Pant institute of post graduate medical education and research |
Room number 329, Academic Block, Department of pathology, G B Pant institute of post graduate medical education and research, Jawaharlal Nehru Marg, Delhi gate, New Delhi, Delhi 110002
Central
DELHI |
8130809433
rprasadshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals (Lok Nayak, G B Pant institute of Post Graduate Medical Education (GIPMER) and Research Hospital, Guru Nanak Eye Centre, New Delhi-110002)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Histopathological diagnosis of gastric or gastroesophageal junction adenocarcinoma |
|
| ExclusionCriteria |
| Details |
Patients on neoadjuvant therapy, recurrent gastric/gastroesophageal junction adenocarcinoma and inadequate biopsy material. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of cases showing expression of HER2 low expression in Gastric and Gastroesophageal adenocarcinoma. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association of HER2 low expression with clinical parameters i.e age, sex & duration of symptoms.
2.Association of HER2 low expression with histopathological features i.e tumor grade, tumor stage, histological subtype, H. pylori status. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma is the fifth most common malignancy and the third leading cause of cancer-related mortality worldwide. Adenocarcinoma is the most common type of gastric cancer. These cancers have poor prognosis and surgery is the only potentially curative approach. Neoadjuvant or adjuvant chemotherapy should be combined with surgery in locally advanced cases. 15-20% of gastric and GEJ carcinoma is associated with HER2 overexpression. Human epidermal growth factor receptor 2 (HER2) is a member of epidermal growth factor receptor family which has tyrosine kinase activity and plays a role in cell proliferation and survival.Recently, trastuzumab deruxtecan (T-DXd)-an antibody drug conjugate (ADC) consisting of an anti-HER2 antibody with a cytotoxic topoisomerase I inhibitor demonstrated superior efficacy to standard cytotoxic chemotherapies in patients with HER2-positive G/GEJ adenocarcinoma and showed some efficacy in HER2 low carcinoma. This study aims to assess the prevalence of HER2- low (HER2 1+ or 2+ without amplification) in gastroesophageal junction and gastric adenocarcinoma, and to evaluate its association with clinical and histopathological features. |