| CTRI Number |
CTRI/2019/11/021957 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
10/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
INTRATUMOR HORMONE RECEPTOR HETEROGENEITY IN BREAST CANCER. |
|
Scientific Title of Study
|
ASSESSMENT OF HORMONE RECEPTOR EXPRESSION
HETEROGENEITY IN CARCINOMA BREAST:AN IMMUNOHISTOCHEMICAL
STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA YADAV |
| Designation |
PG RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PATHOLOGY MAULANA AZAD MEDICAL COLLEGE NEW DELHI
Central
DELHI
110002
India |
| Phone |
8527626343 |
| Fax |
|
| Email |
priyankayadavnb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NITA KHURANA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE NEW DELHI |
| Address |
DEPARTMENT OF PATHOLOGY MAULANA AZAD MEDICAL COLLEGE NEW DELHI
Central
DELHI
110002
India |
| Phone |
9968604289 |
| Fax |
|
| Email |
nitakhurana@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA YADAV |
| Designation |
PG RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PATHOLOGY MAULANA AZAD MEDICAL COLLEGE NEW DELHI
Central
DELHI
110002
India |
| Phone |
8527626343 |
| Fax |
|
| Email |
priyankayadavnb@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE NEW DELHI |
|
|
Primary Sponsor
|
| Name |
PRIYANKA YADAV |
| Address |
DEPARTMENT OF PATHOLOGY MAULANA AZAD MEDICAL COLLEGE NEW DELHI |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| PRIYANKA YADAV |
MAULANA AZAD MEDICAL COLLEGE NEW DELHI |
ROOM NO 62 DEPARTMENT OF PATHOLOGY MAULANA AZAD MEDICAL COLLEGE NEW DELHI
Central
DELHI |
8527626343
priyankayadavnb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1 Newly diagnosed cases of breast carcinoma.
2 Age more than 18 year.
3 Willing to get treated in the same hospital
|
|
| ExclusionCriteria |
| Details |
1 Previous endocrine or chemotherapy
2 Patients undergone lumpectomy as diagnostic procedure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMMUNOHISTOCHEMICAL VARIATION IN ER PR HER2NEU |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASSOCIATION OF HORMONE RECEPTOR EXPRESSION WITH REPONSE TO CHEMOTERAPY |
6 MONTHS |
|
|
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)
|
30/11/2019 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY IS AN OBSERVATIONAL IMMUNIHISTOCHEMICAL STUDY WHICH AIMS AT STUDYING THE VARIANCE IN ER PR HER2NEU EXPRESSION IN SAMPLE OBTAINED VIA TRUCUT BIOPSY AND THEIR COMPLETE EXCISION SPECIMEN AND ALSO THE VARIANCE OCCURING DUE TO CHEMOTHERAPY. |