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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Breast Cancer Patients, |
|
Intervention / Comparator Agent
|
|
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. |