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CTRI Number  CTRI/2025/02/081202 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An LED-based device helps to screen cervical cancer by studying cervical tissue in women aged 18 and above 
Scientific Title of Study   Dual Wavelength assisted, handheld and cost effective LED based device for cervical cancer screening in rural areas 
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 Jijo Lukose 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India 
Phone  9164906655  
Fax    
Email  Jijo.lukose@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Jijo Lukose 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India 
Phone  9164906655  
Fax    
Email  Jijo.lukose@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jijo Lukose 
Designation  Assistant Professor (senior scale) 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Department of Atomic and Molecular Physics LG 01 AB 5 MIT Manipal Academy of Higher Education Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India 
Phone  9164906655  
Fax    
Email  Jijo.lukose@manipal.edu  
 
Source of Monetary or Material Support  
Department of Biotechnology 
 
Primary Sponsor  
Name  Department of Biotechnology 
Address  6th-8th Floor, Block 2 and 4th-5th Floor, Block 3 CGO Complex, Lodhi Road New Delhi - 110 003.India 
Type of Sponsor  Government funding agency 
 
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 Rekha Upadhya  Kasturba medical college MAHE Manipal  Department of Obstetrics and Gynecology KMC Manipal Udupi Karnataka 576104 India
Udupi
KARNATAKA 		 9986143120

rekha.upadhya@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 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  Only women have age of above 18 will be included for the study. All the patients who need a biopsy for cervical cancer diagnosis are included in the study. 
 
ExclusionCriteria 
Details  All male, and female below age 18 are excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The outcome will be a cost effective, optical fiber based handheld device which can be used for screening of cervical abnormalities amongst the rural population in India.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Once the device is developed, it can be easily carried out for field applications such as primary health centers, medical camps etc. for mass screening.  2 year 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   01/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   In the case of gynecological cancers the cervical cancer is the most common type of cancer which causes more number of death cases in developing countries. Though there are immense work using different sources and imaging techniques in the national scenario, there is no instrument in the market available till date that has proven its worth and reliability in cervical cancer screening. Most of the instruments in the market are imaging which do not look into the anatomical changes of the tissues and is not reliable. The subtlety in the tissue based measurement is validated by point measurements. With the advent of technology, a very sensitive and good detector can play an important role in getting signal from as low as one LED.  There have been no reports on point measurements using LED. Hence, a low cost and non-invasive method of detection of early stages of cervical malignancy can be achieved using this technique. 
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