| CTRI Number |
CTRI/2024/07/069977 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Expression of Enhancer of Zeste Homologue 2 (EZH2) and CD49f in breast cancer |
|
Scientific Title of Study
|
Expression of Enhancer of Zeste Homologue 2 (EZH2) and CD49f in breast cancer and its association with clinicopathological features |
| 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 Vandana Thakur |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of pathology, Maulana Azad Medical College, New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg,New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9868364761 |
| Fax |
|
| Email |
thakur.vandana03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Tomar |
| Designation |
Professor, Department of Pathology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology,Maulana Azad Medical College,New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg,New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9711972630 |
| Fax |
|
| Email |
drreenat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Tomar |
| Designation |
Professor, Department of Pathology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pathology,Maulana Azad Medical College,New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg,New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9711972630 |
| Fax |
|
| Email |
drreenat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, 2-Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Vandana Thakur |
Maulana Azad Medical College |
Department of Pathology,Room No. 62, Maulana Azad Medical college, Bahadur Shah Zafar Marg, New Delhi-11002
Central
DELHI |
9868364761
thakur.vandana03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed female patients of breast carcinoma whose biopsy specimens are received in Department of Pathology, MAMC |
|
| ExclusionCriteria |
| Details |
Patients with prior neoadjuvant chemotherapy and/or radiation therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of EZH2 and CD49f in breast carcinoma |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) The association of EZH2 and CD49f with clinicopathological features of breast carcinoma like clinical stage, histological grade, tumor size and Tumor Infiltrating Lymphocytes(TILs)
2) The association of EZH2 and CD49f with percentage of Estrogen receptor, Progesterone receptor, Her2neu, Ki67 status |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/07/2024 |
| 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
|
Breast cancer is one of the most common tumor in women worldwide, with an estimated number of 2.3 million new cases globally. It is one of the leading causes of female mortality worldwide. To improve the prognosis and outcome of the disease, it is imperative to explore the comprehensive molecular mechanism underlying breast cancer.
This study is a cross sectional observation study on expression of Enhancer of zeste homolog 2 (EZH2) and CD49f in breast cancer and its association with clinicopathological features, that will be conducted in Department of Pathology, Maulana Azad Medical College, New Delhi, India. The primary outcome measures the prevalence of EZH2 and CD49f in breast carcinoma. The secondary outcome will be association of EZH2 and CD49f with clinicopathological features, Estrogen receptor, Progesterone receptor, Her2neu and Ki67 status |