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CTRI Number  CTRI/2021/07/034792 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Impact of geriatric assessment tools on 1- year mortality in non-metastatic breast cancer patients 65 years and older 
Scientific Title of Study   PROspecTive Study on the use of gEriatriC assessment Tools for validation of 1- year mortality in non-metastatic breast cancer patients 65 years and older  
Trial Acronym  PROTECT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tabassum Wadasadawala 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  91-22-24177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tabassum Wadasadawala 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  91-22-24177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shivani Sable 
Designation  Junior Resident 2 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  09561096710  
Fax    
Email  shivanisable.44@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre 
 
Primary Sponsor  
Name  Tata Memorial Center 
Address  Tata Memorial Centre, Dr Ernest Borges Home, Parel, Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tabassum Wadasadawala  Tata Memorial Centre  Department of Radiation oncology, Homi Bhabha building room 105/108, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
2224177000-6116

twadasadawala@actrec.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a study of geriatric breast cancer patients 
 
ExclusionCriteria 
Details  1. Not willing to participate
2. Unable to understand the questionnaires 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Cumulative incidence of 1 year mortality.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Validation of MPI and Onco-MPI for 1-year mortality.
2. Comparison of outcome using MPI and Onco-MPI with conventional prognostic factors.
3. To study quality-of-life using the WHO BREF questionnaire pre- and post-treatment.
4. To study the impact of cancer treatment on the systemic organ functions pre-and post-treatment.
5. Sensitivity of G8 and VES-13 as screening tools for geriatric assessment
6. 2-year mortality
 
2 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/07/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The proposed study focuses on assessing the older patients (>/= 65 years) by using three geriatric scales. The aim of the study is to detect various problems faced by the older patients undergoing treatment for breast cancer. These include health related, social, psychological and economic problems. The four scales which will be used are Multidimensional prognostic index and Onco-multidimensional prognostic index, both of which involves a detailed assessment, VES-13 and G8 which are shorter tools. This assessment will be carried out at the beginning of the cancer directed treatment so that we can understand how treatment decisions (and subsequent survival) are affected by various factors in elderly patients. The quality of life will also be assessed using WHO-BREF questionnaire, which will be given at the time of initial assessment, after the completion of treatment and also during follow up every 6 months till 2 years. The   survival outcome and quality of life will be studied in relation to the geriatric scales data. Moreover, the usefulness of the short tools (G8 and VES-13) will be studied with respect to the longer MPI & onco-MPI tool to understand feasibility for routine clinical use. The study will be conducted over a 4-year period, 2 years for accrual of 300 patients and 2 years for follow up.

 
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