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CTRI Number  CTRI/2022/11/047329 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 14/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study on survival analysis and predictors of mortality among breast cancer patients 
Scientific Title of Study   Survival analysis and predictors of mortality among breast cancer patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Walarisa Lamare 
Designation  Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9986813499  
Fax    
Email  walarisalamare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uday Venket Mateti 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Jayarama Shetty 
Designation  Professor, HOD of Radiation therapy and Oncology 
Affiliation  Justice K S Hegde Charitable Hospital (Nitte Deemed to be University) 
Address  KS Hegde Medical Academy Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  jayarama.shetty@nitte.edu.in  
 
Source of Monetary or Material Support  
KS Hegde Charitable Hospital, Deralakatte, Mangalore 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [] 
 
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 
Ms Walarisa Lamare  Justice K S Hegde Charitable Hospital  Medical Record Department
Dakshina Kannada
KARNATAKA 		 9986813499

walarisalamare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee( NGSMIPS-IEC)  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  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  All the Breast cancer participants who were treated in the last 6 year in Justice KS Hedge
Hospital.
Breast Cancer participants with clear information about the clinical characteristics and treatment
will be incorporated in the study. 
 
ExclusionCriteria 
Details  Participant’s with incomplete follow-up and incomplete data in case files will be excluded.
Participants /caretakers who doesn’t respond to phone calls will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the survival status among breast cancer patients.  Single point 
 
Secondary Outcome  
Outcome  TimePoints 
To identify predictors of mortality among breast cancer patients.  Single point 
 
Target Sample Size   Total Sample Size="596"
Sample Size from India="596" 
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)   16/11/2022 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   INTRODUCTION: Breast cancer is a familiar type of cancer and is the major causes of death among women in global level. Breast cancer was identified in 2.3 million women globally in which 6,85,000 were deceased worldwide in the year 2020. Total of 7.8 million women who were alive with breast cancer in the past 5 years by the end of 2020.
OBJECTIVES OF THE STUDY: To estimate the survival status among breast cancer patients and to identify predictors of mortality among breast cancer patients.
JUSTIFICATION FOR THE STUDY: The mortality rate among breast cancer women in India is about 23.5% whereas it is around 16.2% in European countries. The 5 years survival among the breast cancer patients after diagnosis in India is about 66% which is very poor in compared to the developed country Le.. 90% Thus, it is necessary to study the factors and predictors responsible for the poor survival and higher mortality rate among Indian women. Hence, our study aims to study the predictors associated with survival and mortality among breast cancer patients.
METHODOLOGY: A Retrospective cohort study will be conducted for a duration of 8 months. The data will be collected on participants socio-demographics such as age, religion, marital status, residence, education status, occupational status and family history. Clinical characteristics such as menopausal status, stage of breast cancer, histology, tumor grade, nodal states and distant metastasis and type of breast cancer therapy, scoring for breast cancer mortality. Therapy such as breast cancer surgery chemotherapy, hormone therapy and radiotherapy and telephone interview will be collected.
STATISTICAL ANALYSIS: Data analysis will be performed using SPSS 240 Kaplan-Meier curve to estimate overall survival. Log rank test will be used to compare survival among groups with a confidence interval of 95% p-value <0.5 will be considered statistically significant. ’Cas Proportional Hazard regression model will be analyzed
OUTCOME MEASURES: The outcome of this study is to estimate the predictors of survival rate and mortality rate in relation with clinical status of breast cancer patient.
 
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