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
|
|
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. |