| 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
|
|
|
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
|
|
|
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. |