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CTRI Number  CTRI/2023/01/048965 [Registered on: 12/01/2023] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on prevalence and risk of Breast cancer in Manipal  
Scientific Title of Study   Prevalence and risk factors associated with Breast cancer among patients attending a cancer hospital in Manipal 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharshana P 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Welcomgroup Graduate School of Hotel Administration, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9003485192  
Fax    
Email  dharshana.p@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Namratha Pai K 
Designation  Assistant professor 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Welcomgroup Graduate School of Hotel Administration, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Namratha Pai K 
Designation  Assistant professor 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Welcomgroup Graduate School of Hotel Administration, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Source of Monetary or Material Support  
Department of Medical Oncology, Shiridi Sai Baba Cancer Hospital and Research Center, Manipal, Udupi - 576104 
 
Primary Sponsor  
Name  Dharshana P 
Address  Welcomgroup Graduate School of Hotel Administration, MAHE, Madhav Nagar, Manipal - 576104 
Type of Sponsor  Other [SELF] 
 
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 Karthik S Udupa  Shiridi Sai Baba Cancer Hospital and Research Center  First floor, Department of Medical Oncology, Shiridi Sai Baba Cancer Hospital and Research Center, Manipal
Udupi
KARNATAKA 		 08202922126

udupa.karthik@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
The Institutional Research Committee WGSHA  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  70.00 Year(s)
Gender  Both 
Details  The study covered all types of histopathologically confirmed cases of breast cancer, regardless of their degree, in the age category of 18 to 70 years. 
 
ExclusionCriteria 
Details  Patients who have not given consent to participate in the study, as well as those who are terminally ill, post-surgical cases and aged <18 or >70 years will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the prevalence and risk factors associated with Breast cancer  One single point 
 
Secondary Outcome  
Outcome  TimePoints 
To identify new risk factors associated with Breast cancer, if any.  One single point 
 
Target Sample Size   Total Sample Size="187"
Sample Size from India="187" 
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)   16/01/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dharshananathan8@gmail.com].

  6. For how long will this data be available start date provided 26-11-2022 and end date provided 31-12-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Cancer has risen to become one of the top ten causes of death in India. Breast cancer is the most diagnosed malignancy in India, after cervical cancer. An increasing trend in incidence has been documented from several registries of the national cancer registry project, and India is now the country with the highest estimated number of breast cancer fatalities worldwide. The reasons for the varying prevalence of breast cancer among women are not entirely known but are believed to be explained by reproductive and lifestyle factors such as literacy, diet, age at menarche and menopause, age at first delivery, abortion, and a family history of breast cancer. 

This study is to identify the prevalence and risk factors, both known and unknown, associated with Breast cancer among the patients attending a cancer hospital in Manipal. 

The study includes all types of histopathologically confirmed cases of breast cancer, regardless of their degree, in the age category of 18 to 70 years. Patients who have not given consent to participate in the study, as
well as those who are terminally ill, post-surgical cases and aged <18 or >70 years will be excluded.

Face-to-face interviews and Anthropometric examination will be part of this cross- sectional clinical survey. In-person interviews based on a self-designed structured questionnaire will be used to collect data. Anthropometric instruments like measuring tape, weighing scale and Harpenden Skinfold Caliper will be used.
 
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