| 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
|
|
|
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
|
|
|
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. |