| CTRI Number |
CTRI/2022/08/044693 [Registered on: 16/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of clinicopathological pattern in young breast cancer |
|
Scientific Title of Study
|
Study of clinicopathological and immunohistochemical features in young breast cancer patients in a super speciality cancer centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ajay yadav |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of medical oncology
SRCC Building
Mahatma Gandhi Medical College Hospital
Sitapura
Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
08826914083 |
| Fax |
|
| Email |
drajayyadav@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
ajay yadav |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of medical oncology
SRCC Building
Mahatma Gandhi Medical College Hospital
Sitapura
Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
08826914083 |
| Fax |
|
| Email |
drajayyadav@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
ajay yadav |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of medical oncology
SRCC Building
Mahatma Gandhi Medical College Hospital
Sitapura
Jaipur
Jaipur
RAJASTHAN
302015
India |
| Phone |
08826914083 |
| Fax |
|
| Email |
drajayyadav@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical college and Hospital sitapura Jaipur Rajasthan India |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NA |
| Type of Sponsor |
Other [NO SPONSER] |
|
|
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 |
| ajay yadav |
DEPARTMENT OF MEDICAL ONCOLOGY MAHATMA GANDHI MEDICAL COLLEGE HOSPITAL JAIPUR RAJASTHAN |
Department of Medical Oncology
Sri Ram Cancer Center
Mahatma Gandhi Medical College & Hospital
Mahatma Gandhi University of Medical Sciences and Technology
Sitapura Jaipur302022
Jaipur
RAJASTHAN |
08826914083
ajayalwar01@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Mahatma gandhi medical college and hospital jaipur |
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
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female Patients < 40 years, with Breast cancer |
|
| ExclusionCriteria |
| Details |
Female Patients > 40 years with Breast cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical and pathological pattern in young breast cancer patients |
The study duration will be one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/08/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is retrospective observational study Study will be started after CTRI registration |