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CTRI Number  CTRI/2014/09/004972 [Registered on: 04/09/2014] Trial Registered Retrospectively
Last Modified On: 03/09/2014
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Breast Cancer Registry to collect epidemiological data, treatment patterns & outcomes of breast cancer patients in India 
Scientific Title of Study   Breast Cancer Registry to collate data on epidemiology and treatment patterns & outcomes of breast cancer in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinod Raina 
Designation  Director and Head, Department of Medical Oncology and Haematology, 
Affiliation  Fortis Memorial Research Institute  
Address  Sector 44,

Gurgaon
HARYANA
122002
India 
Phone  01244962200  
Fax  01126513437  
Email  vinod.raina@fortishealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinod Raina 
Designation  Director and Head, Department of Medical Oncology and Haematology, 
Affiliation  Fortis Memorial Research Institute  
Address  Sector 44,

Gurgaon
HARYANA
122002
India 
Phone  01244962200  
Fax  01126513437  
Email  vinod.raina@fortishealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinod Raina 
Designation  Director and Head, Department of Medical Oncology and Haematology, 
Affiliation  Fortis Memorial Research Institute  
Address  Sector 44,

Gurgaon
HARYANA
122002
India 
Phone  01244962200  
Fax  01126513437  
Email  vinod.raina@fortishealthcare.com  
 
Source of Monetary or Material Support  
Roche Products (India) Private Limited 
 
Primary Sponsor  
Name  Dr Vinod Raina 
Address  Fortis Memorial Research Institute Sector 44, Gurgaon, Haryana 122002, India  
Type of Sponsor  Other [India Breast Cancer Registry Group] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemant Malhotra  Birla Cancer Center  SMS Medical College Hospital, Division of Medical Oncology, C-70, Ram Marg, Tilak Nagar, Jaipur - 302004
Jaipur
RAJASTHAN 
0141-2620600

drmalhotrahemant@gmail.com 
Dr Amit Agarwal  BLK Super Speciality Hospital  Department of Medical Oncology, Pusa Road, Rajendra Place, New Delhi, DL 110005
New Delhi
DELHI 
9971611311

deepaliamit@hotmail.com 
Dr Boman Dhabhar  Fortis Hospital, Mulund  Department of Oncology, Goregaon - Mulund Link Rd, Bhandup Industrial Area, Industrial Area, Mulund West
Mumbai
MAHARASHTRA 
9820344570

drboman@hotmail.com 
Dr Vinod Raina  Fortis Memorial Research Institute  FMRI, Department of Medical Oncology & Haematology Sector 44, Gurgaon PIN:122002
Gurgaon
HARYANA 
01244962200
01126513437
vinod.raina@fortishealthcare.com 
Dr Ramesh Sarin  INDRAPRASTHA APOLLO HOSPITALS  Department of Surgical Oncology, Sarita Vihar, Delhi Mathura Road, New Delhi-110 076
New Delhi
DELHI 
9810064496

sarinramesh@hotmail.com 
Dr Vinay Deshmane  P.D Hinduja National Hospital and Medical Research  Surgical Oncology & Breast Diseases, Veer Savarkar Marg,cadell road, Mahim West
Mumbai
MAHARASHTRA 
9820301990

deshmanevinay@hotmail.com 
Dr NK Warrier  Prateeksha Oncology Clinic  29 /.1000 A. Madakkuni Temple Road, Near Kottooli Petrol Pump
Kozhikode
KERALA 
0495-2740995

n_goray@rediffmail.com 
Dr Dinesh Doval  Rajiv Gandhi Cancer Institute & Research Centre  Department of Medical Oncology, Room number 2252 Sector - 5, Rohini, Delhi - 110 085, India
North West
DELHI 
011-47022222

ddoval07@gmail.com 
Dr Sudeep Gupta  Tata Memorial Hospital  Deputy Director, (CRC) ACTREC Room 305, 3rd Floor, Paymaster Shodhika, ACTREC (Advanced Centre for Treatment, Research and Education in Cancer) Dr. Ernest Borges Marg, Parel
Mumbai
MAHARASHTRA 
022-24177201

sudeepgupta04@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Dr. B L Kapur Memorial Hospital Ethics Committee  Submittted/Under Review 
Ethics Committee on Clinical Trials, Apollo Hospitals  Approved 
Ethics Committee, SMS Medical College, Jaipur  Approved 
Fortis Hospital Mulund Ethics Committee   Submittted/Under Review 
Institute Ethics Committee, PD Hinduja National Hospital and Medical Research Center  Approved 
Institutional Ethics Committee, Fortis Memorial Research Institute  Approved 
Institutional Ethics Committee, MIMS  Approved 
Institutional Review Board, Ragiv Gandhi Cancer Institute & Research Centre  Approved 
Institutional review Board, Tata Memorial Hosptal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breast Cancer Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Newly diagnosed early breast cancer patients
• Newly diagnosed metastatic breast cancer patients
• Patient diagnosed as early breast cancer progressed to mBC and not treated for metastatic disease( i.e. first line mBC patients)
 
 
ExclusionCriteria 
Details  • 2nd line metastatic breast cancer patients i.e. mBC patient treated earlier for their metastatic disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportions of new Breast Cancer patients
Proportions of patients with recurrence, progression of disease, survival and death 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proportions of patients with recurrence, progression of disease, survival and death  12 months 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   25/10/2013 
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)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is the commonest cancer in women in urban India and accounts for about 25% to 33% of all cancers in women. Most of the risk factors and other features of breast cancer are usually identical round the world. However, each country has unique characteristics of cancer. e.g. about 50-55% of breast cancer cases were detected at late (III and IV) stage; in contrast to the 15% in US. Estrogen (ER) and HER2 are currently used in routine pathological assessment of breast cancer due to their predictive and prognostic role in management of breast cancer. Present Indian data is limited to few centers involved in population based cancer registry or of individual centers only. This may not reflect actual national incidence and frequencies of above mentioned aspects of breast cancer.

Objective

  • To register new Breast Cancer patients and record their demographic, clinical and pathological features.
  • To collate information on clinical course of the disease, treatment and after therapy follow-up.
  • To collate the epidemiological data with emphasis on the biological markers in breast cancer
  • To explore possibility to launch a national registry based on initial experience.

The data of breast cancer patient will be collected prospectively in new patients with the help of web based software or patient registry tool (PRT). Decisions related to treatment would be the choice of the treating doctor. Within a week of assessment/visit to OPD, the patient’s data from medical records will be entered using PRT. The registry will record the data available on demographics, relevant history, treatment given, recurrence and progression of disease, last follow up & death.  

 
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