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CTRI Number  CTRI/2024/07/070659 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Comparing conventional Pap Smear with Liquid-Based Cytology for screening Cervical Cancer. 
Scientific Title of Study   Comparison of Conventional Pap Smear and Liquid Based Cytology in Screening of Cervical Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raj Aravind Kamatchi 
Designation  Post Graduate Resident 
Affiliation  BPS GMC, KHANPUR KALAN 
Address  Department of Pathology, BPS GMC, Khanpur Kalan, Sonipat, Haryana

Sonipat
HARYANA
131305
India 
Phone  8825626993  
Fax    
Email  rajkaravind13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ruchi Agarwal 
Designation  Professor 
Affiliation  BPS GMC, KHANPUR KALAN 
Address  Department of Pathology, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat, Haryana.

Sonipat
HARYANA
131305
India 
Phone  9215340907  
Fax    
Email  pg.ruchi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ruchi Agarwal 
Designation  Professor 
Affiliation  BPS GMC, KHANPUR KALAN 
Address  Professor, Department of Pathology, Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat, Haryana.

Sonipat
HARYANA
131305
India 
Phone  9215340907  
Fax    
Email  pg.ruchi@gmail.com  
 
Source of Monetary or Material Support  
BPS GMC(Women), Khanpur Kalan, Sonipat, Haryana, India - 131305 
 
Primary Sponsor  
Name  BPS GMCWomen Khanpur Kalan Sonipat 
Address  Department of Pathology, BPS Government medical college, Khanpur Kalan, Sonipat, Haryana. Pincode 131305 
Type of Sponsor  Government medical college 
 
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 Raj Aravind Kamatchi  Bhagat Phool Singh Government Medical College for Women Khanpur Kalan  Department of Pathology, BPS Government medical college, Khanpur Kalan, Sonipat, Haryana. Pincode 131305
Sonipat
HARYANA 
8825626993

rajkaravind13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBPSGMC  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 
Intervention  conventional pap smear  The speculum gives a clear view of the cervix and upper vagina. Cells are removed from the cervix with a brush or other sampling instrument. The cells usually are put into a special liquid and sent to a laboratory for testing: For a Pap test, the sample is examined to see if abnormal cells are present. The intervention will be done for a period of 1 year. 
Comparator Agent  Liquid based cytology  The cervical cells are taken by cytobroom by rotating over cervix five times and then put in preservative liquid. Centrifuged in Eziprep machine. Smear is prepared for microscopic examination. Comparator will be used for a period of 1 year. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  All female above 21 years of age 
 
ExclusionCriteria 
Details  1. Patients with diagnosis of CIN or cervical cancer and under treatment,
2. Pregnant and postpartum female,
3. Women in their menstrual period,
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the superior test will be known after the study  one year 
 
Secondary Outcome  
Outcome  TimePoints 
The superior test among the Conventional Pap Smear & Liquid Based Cytology in Screening of Cervical Cancer will be known.  one year 
 
Target Sample Size   Total Sample Size="171"
Sample Size from India="171" 
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   Phase 2 
Date of First Enrollment (India)   29/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

WHO has started a worldwide program to expand prevention, screening and treatment efforts to eradicate cervical cancer as a public health issue in the 21st century. A delayed diagnosis and a poor prognosis for cervical cancer may result from a lack of knowledge of screening procedures, risk factors and symptoms. There was relatively little knowledge of symptoms and risk factors in both rural and urban settings. Therefore many awareness programmes and screening are highly required to diagnose cervical cancer in prior.1 The American College of Obstetricians and Gynecologists (ACOG) guidelines 2021, recommends the screening for cervical cancer from 21 years of age and then every 3 years.18

 

Cervical cancer is preceded by squamous intraepithelial lesions which can be detected before it becomes invasive and this serves as the basis of the cytological screening. The abnormal cells shed by the cervical lesions can be detected on cytological examination. In cervical cancer screening, the papanicoloau smear also known as pap smear plays a significant role on the morbidity and mortality from cervical cancer. Ayre’s spatula and cyto brush are used to collect sample from cervix. The samples are fixed using ethyl alcohol and stained with papanicoloau stain for microscopic examination. The pap test detects most cervical neoplasia during the usually prolonged premalignant or early occult malignant phases.3

 

 Liquid-based cytology (LBC), the monolayer slide preparation method has proven to be more effective than traditional pap smears due to its enhanced fixation, reduced obscuring factors and consistent cell transfer. In LBC, samples are collected by completely immersing the sampling device into the vial containing preservative fluid, whereby the cells are preserved and fixed simultaneously. This enhances the quality of screening by preserving the morphology of the cells to be examined.4

 

Prevention of cervical cancer lies mainly in early detection and thus regular screening is recommended. The present study is undertaken to compare the conventional pap smear and liquid based cytology in cervical cancer screening.  


 
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