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CTRI Number  CTRI/2024/08/071996 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Breast and cervical cancer screening among women in Udupi district 
Scientific Title of Study   Early detection, referral and treatment for breast and cervical cancer among women - A population-based study in Udupi district, Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjitha S Shetty 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Community Medicine Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjitha S Shetty 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Community Medicine Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka


KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjitha S Shetty 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Community Medicine Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka


KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Foundation Prestige Emerald, 5th Floor, # 4, Madras Bank Road, Bangalore 560001, Karnataka, INDIA 
 
Primary Sponsor  
Name  Manipal Foundation 
Address  Manipal University Building, Ground Floor, Madhava Nagar, Manipal – 576104, Karnataka 
Type of Sponsor  Other [Registered Trust] 
 
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 Ranjitha S Shetty  Kasturba Medical College, Manipal  Room No. 5, Department of Community Medicine,3rd Floor, Biochemistry Building, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Madhava Nagar, Manipal
Udupi
KARNATAKA 
9110401395

ranjitha.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening for Cervical and Breast cancer mainly and screening for hypertension, diabetes and anemia among women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Not applicable 
Comparator Agent  Nil  Not applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Women in the age group 30 years – 55 years
2. Women give written informed consent 
 
ExclusionCriteria 
Details  1. Women previously diagnosed with breast cancer and cervical cancer and who are on treatment.
2. Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Cancer screening profile of rural and semi-urban women from Udupi district
• Establishing a referreal pathway for cancer screening and treatment
• Capacity building of the CHWs at community centers in VIA-AI procedure
• Validation of SAKHI -Manipal device for cervical cancer screening
 
July 2024 to December 2025  
 
Secondary Outcome  
Outcome  TimePoints 
Hypertension, diabetes and anemia profile of screened women  July 2024 to December 2025  
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
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)
Modification(s)  
12/08/2024 
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="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective cross-sectional study to be conducted among women in the age group of 30-55 years within Udupi district.

Objectives of the study:

1.Screening rural women for breast and cervical cancers, anemia, hypertension and type II diabetes in Udupi district.

2.Establishing a referral pathway and follow-up mechanism for the management of women with positive findings with the screening procedures.

3.Assessing the usefulness of Validation of the AI-enabled cervical cancer screening tool -Sakhi Manipal, in terms of image quality, user-friendliness and accuracy 

Sample size: Complete enumeration of all participants who come forward for screening during the study period (approximately 4000 within the study period).

Methodology:

Tool for data Collection:

Semi-structured interview-based questionnaire on Epicollect5 to collect study participant information and document the findings of the screening tests and referral details.

Tool for Breast cancer screening -  iBE ( iBreast Exam) - The iBE is an FDA 510(k) cleared non-invasive and low-cost technique for early detection of clinically relevant breast lesions using a handheld point-of-care medical device. iBE utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities (Sensitivity = 84 %; Specificity = 94 %; PPV = 60 %; NPV = 98 %.)

Tool for cervical cancer screening : Visual inspection after acetic acid test using an indigenously designed, AI-enabled image capture device called SAKHI-Manipal (VIA-AI). SAKHI-Manipal has a sensitivity and specificity of 86.75% and 87.65% respectively. VIA will be reported by the healthcare workers and by the AI. When there is disagreement in reports, an expert will evaluate the respective images and will provide the final decision.  Additionally, a Pap smear also will be obtained.

BP measurement (using a digital BP apparatus), RBS estimation (using a glucometer), and HB estimation (finger prick method using a portable hemoglobinometer) will also be done as part of this screening activity

Written informed consent will be taken from all the participants of the study. Privacy, anonymity  and data confidentiality will be maintained throughout the study.

Screening will be in two settings:

Awareness sessions will be held for 30 minutes prior to screening.

1.            At community level, for the women who report for well women screening after the community mobilization.

2.            At KH Manipal for the women workforce and the spouses/ family members of men workforce, both belonging to below poverty line economic groups. The HR department of the hospital will help in mobilizing the women for awareness activity as well as screening.

 
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