| CTRI Number |
CTRI/2019/10/021652 [Registered on: 15/10/2019] Trial Registered Prospectively |
| Last Modified On: |
11/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying the risk factors for breast cancer in Indian women. |
|
Scientific Title of Study
|
Development of breast cancer risk prediction model using lifestyle factors and polygenic risk score in Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Dikshit |
| Designation |
Director , Centre For Cancer Epidemiology |
| Affiliation |
Centre For Cancer Epidemiology, Tata Memorial Centre |
| Address |
Centre For Cancer Epidemiology, Advanced Centre for Treatment Research and Education in Cancer, Utsav Chowk - CISF Rd, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
91996951884 |
| Fax |
|
| Email |
dixr24@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Dikshit |
| Designation |
Director , Centre For Cancer Epidemiology |
| Affiliation |
Centre For Cancer Epidemiology, Tata Memorial Centre |
| Address |
Centre For Cancer Epidemiology, Advanced Centre for Treatment Research and Education in Cancer, Utsav Chowk - CISF Rd, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
91996951884 |
| Fax |
|
| Email |
dixr24@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Dikshit |
| Designation |
Director , Centre For Cancer Epidemiology |
| Affiliation |
Centre For Cancer Epidemiology, Tata Memorial Centre |
| Address |
Centre For Cancer Epidemiology, Advanced Centre for Treatment Research and Education in Cancer, Utsav Chowk - CISF Rd, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
91996951884 |
| Fax |
|
| Email |
dixr24@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr. E Borges Road, Parel, Mumbai - 400 012 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manigreeva Krishnatreya |
Dr B. Borooah Cancer Institute |
AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Dibrugarh
ASSAM |
9954480612
manigreeva@gmail.com |
| Debashis Chaudhary |
Homi Bhabha Cancer Hospital |
Emergency Of Civil Hospital, Mubarik Mehal Colony, Sangrur, Punjab 148001
Sangrur
PUNJAB |
9869827016
Debashish.chaudhary@gmail.com |
| Giridhar CM |
Homi Bhabha Cancer Hospital |
Marripalem, Aganampudi Village, Gajuvaka Mandalam, NH16, Visakhapatnam, Andhra Pradesh 530053
Visakhapatnam
ANDHRA PRADESH |
08921727634
cmgiridhar@gmail.com |
| Bhagwan Nene |
Nargis Dutt Memorial Cancer Hospital |
Barshi Rd, Industrial Estate No.2, Barshi, Maharashtra 413401
Solapur
MAHARASHTRA |
9422647412
iecndmch@gmail.com |
| Naveen Khargekar |
Pandit Madan Mohan Malviya Cancer Hospital |
Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
9867191421
naveenkhargekar@gmail.com |
| Dr Rajesh Dikshit |
Tata memorial Hospital |
Dr. E Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA |
919969518844
dixr24@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC,Dr B. Borooah Cancer Institute |
Submittted/Under Review |
| IEC,Nargis Dutt Memorial Cancer Hospital |
Submittted/Under Review |
| IEC,omi Bhabha Cancer Hospital, Sangrur |
Submittted/Under Review |
| Institutional Ethics committee |
Approved |
| Institutional Ethics committee, Pandit Madan Mohan Malviya Cancer Hospital |
Submittted/Under Review |
| IRB,CCHRC |
Submittted/Under Review |
|
|
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 |
36.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.All new histopathologically &/ or cytologically confirmed primary breast carcinoma cases
2.Females
3.Date of diagnosis less than or equal to 6 months from the date of enrolment
4.Age between 35-65 years
5.Resident of India for at least one year
|
|
| ExclusionCriteria |
| Details |
1.Cases with malignancies other than primary breast carcinoma
2.Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Breast cancer |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="6300"
Sample Size from India="6300"
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)
|
17/10/2019 |
| 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="2"
Months="0"
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
|
It is a multi-center case-control study planned to develop the risk cancer, breast prediction model in an individual woman. The study will be conducted in 2 phases. The first phase includes development of risk prediction model. The second phase is comprised of validation of . The cases and controls will be interviewed on lifestyle, dietary variables using pre-texted questionnaire. 10 ml blood sample will be collected and anthropometric measurements will be taken from each study participant. |