FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022727 [Registered on: 13/01/2020] Trial Registered Prospectively
Last Modified On: 20/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   Breast cancer screening by clinical breast examination and a new instrument named iBreastExam 
Scientific Title of Study   A pilot study for breast cancer screening by clinical breast examination (CBE) and iBreastExam (iBE) for early detection of breast cancer 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smita Joshi 
Designation  Senior Researcher 
Affiliation  Prayas 
Address  Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana
Same as address 1.
Pune
MAHARASHTRA
411004
India 
Phone  9881132506  
Fax    
Email  smitanjoshi18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Joshi 
Designation  Senior Researcher 
Affiliation  Prayas 
Address  Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana
Same as address 1.
Pune
MAHARASHTRA
411004
India 
Phone  9881132506  
Fax    
Email  smitanjoshi18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita Joshi 
Designation  Senior Researcher 
Affiliation  Prayas 
Address  Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana
Same as address 1.
Pune
MAHARASHTRA
411004
India 
Phone  9881132506  
Fax    
Email  smitanjoshi18@gmail.com  
 
Source of Monetary or Material Support  
Prayas, Amrita Clinic, Karve Road Corner, Deccan Gymkhanan, Pune 411004 
 
Primary Sponsor  
Name  Prayas 
Address  Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana, Pune 411004 
Type of Sponsor  Other [non-profit organization] 
 
Details of Secondary Sponsor  
Name  Address 
Atlas Copco Charitable Foundation   Atlas Copco Charitable Foundation C/o Atlas Copco (India) Ltd. Address: Sveanagar, Dapodi Mumbai-Pune road, Pune-411012 Maharashtra, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Joshi  Prayas  Amrita Clinic, Karve Road Corner, Deccan Gymkhana, Pune 411004
Pune
MAHARASHTRA 
9881132506

smitanjoshi18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research   Approved 
Institutional Ethics Committee for Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  breast cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical breast examination  Clinical breast examination (CBE) is a low-cost option for improving breast awareness and early detection of breast cancer. 
Comparator Agent  iBreastExam screening  iBreastExam is a handheld device that uses piezoelectric palpation to enhance the clinical breast exam (CBE) for detection of breast masses 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  69.00 Year(s)
Gender  Female 
Details  Consenting women  
 
ExclusionCriteria 
Details  Women who have undergone breast surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The outcome will be women detected with breast cancer correctly by clinical breast examination and iBreastExam

2. Test performance of clinical breast exam and iBreastExam in detecting breast cancer 
single  
 
Secondary Outcome  
Outcome  TimePoints 
To study the test performance of CBE and iBreastExam in detecting lumps with histopathology as the reference standard
 
cross-sectional 
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="10000" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/01/2020 
Date of Study Completion (India) 30/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Breast cancer is the most common cancer among women in India. Mammography screening is the mainstay of breast cancer screening in the developed / high-income countries however such organized screening programmes are extremely difficult/ expensive to implement in the low- and middle-income countries. Hence alternative screening strategies must be evaluated.    iBreastExam is a new technology that is approved by the USFDA and is approved in India. According to the World Health Organization (WHO), screening programmes should be undertaken only when their effectiveness has been demonstrated, when resources are sufficient to cover nearly all of the target group, when facilities exist for follow-up of those with abnormal results to confirm diagnoses and ensure treatment and when prevalence of the disease is high enough to justify the effort and costs of screening. We are proposing a study to evaluate the diagnostic performance characteristics of  Clinical Breast Examination (CBE)  and iBreastExam for the early detection of breast cancer. Previous studies have been conducted in hospital settings and among women visiting the hospital/ breast clinic. Our study will be conducted in a community setting and women who test positive by either CBE or iBreastExam will be referred to an Expert Breast Surgeon. Those who are detected as being normal / negative by the breast surgeon will be assured and will be sent back. Women who have a lump detected by the breast surgeon on CBE will undergo triple diagnostic tests including FNAC for the final diagnosis.  

 
Close