Cervical Intraepithelial Neoplasia Screening Using Liquid-Based Pap Smear Among Egyptian Women

November 25, 2025 updated by: Tamer Abdelhamid Ahmed Abdelmaksoud, Kasr El Aini Hospital

Cervical Intraepithelial Neoplasia Screening by Liquid-Based Pap Smear in General Gynecological Services Among Egyptian Women

This observational study aims to screen Egyptian women aged 25-60 for cervical intraepithelial neoplasia (CIN) using liquid-based Pap smear during routine gynecological visits at Kasr Al-Aini outpatient clinics. Screening is performed through standardized liquid-based cytology to detect early cellular abnormalities that may indicate precancerous changes or cervical cancer. The goal of the study is to identify abnormal cytology at an early stage, improve early detection of cervical cancer, and provide epidemiological data on cervical abnormalities among women attending general gynecological services.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This cross-sectional observational study was conducted at the Kasr Al-Aini outpatient gynecology clinics, Cairo University. A total of 984 women aged 25-60 years attending routine gynecologic care were enrolled after providing written informed consent. Women with pregnancy, prior hysterectomy, or known cervical lesions requiring diagnostic management were excluded.

Each participant completed a structured interview covering demographic characteristics, reproductive and sexual history, comorbidities, contraception use, and family history of malignancy. A standardized pelvic examination was performed, followed by cervical sampling using a cervical brush or broom. All samples were collected using the liquid-based cytology (LBC) technique, immediately preserved in fixative solution, and processed in the cytopathology laboratory using the ThinPrep system.

Slides were examined by experienced cytopathologists and classified according to the 2014 Bethesda System. Cytology results were categorized as NILM, ASC-US, LSIL, HSIL, or unsatisfactory. The primary objective was to detect any cytological abnormality suggestive of cervical intraepithelial neoplasia. Secondary objectives included describing the demographic and clinical correlates of abnormal cytology and estimating the overall prevalence of abnormal cervical cytology in this population.

The study aims to support earlier detection of cervical abnormalities, reduce progression to invasive cervical cancer, and provide population-based data to guide cervical cancer prevention strategies in Egypt.

Study Type

Observational

Enrollment (Actual)

984

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Al-Aini Hospital - Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics and undergoing routine cervical screening using liquid-based cytology.

Description

Inclusion Criteria:

  • Females aged 25-60
  • Attending Kasr Al-Aini outpatient gynecology clinics
  • Willing to provide informed consent

Exclusion Criteria:

  • • Pregnancy

    • Prior hysterectomy
    • Existing cervical lesions
    • Previous CIN treatment in last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gynecological Screening
Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics who undergo liquid-based Pap smear screening for detection of cervical intraepithelial neoplasia.
Diagnostic test: Liquid-Based Pap Smear (LBC)
Cervical sample collected using a cervical brush or broom and preserved in liquid fixative solution. Slides prepared using ThinPrep liquid-based cytology and reported according to the 2014 Bethesda System. Used for detection of abnormal cervical cytology including ASC-US, LSIL, HSIL, and NILM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Cervical Cytological Abnormalities
Time Frame: At time of screening (single visit)

Presence of cytological abnormalities detected using liquid-based cytology (ThinPrep) and interpreted according to the 2014 Bethesda System.

Unit of measure:

Percentage of participants

Outcome measure tool:

Liquid-based cytology (LBC) using ThinPrep; Bethesda System classification (ASC-US, LSIL, HSIL, NILM, Unsatisfactory).
At time of screening (single visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Abnormal Cervical Cytology
Time Frame: At time of screening

Proportion of screened women found to have abnormal cytology (ASC-US, LSIL, HSIL, or Unsatisfactory).

Outcome Measurement Tool: Liquid-based cytology (ThinPrep) interpreted using the 2014 Bethesda System.

Unit of measure:

Percentage of participants
At time of screening
Correlation Between Participant Characteristics and Abnormal Cytology
Time Frame: At time of screening

Correlation between participant demographic & clinical factors (age, parity, contraceptive use, comorbidities) and presence of abnormal cytology.

Unit of measure:

Correlation coefficient (r)

Measurement tool:

Statistical analysis (Pearson/Spearman correlation)
At time of screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Ahmed M El-Minawi, Professor, Cairo University
  • Study Chair: Yossra Lasheen, Assistant Professor, Cairo University
  • Study Director: Mohamed Aly, Lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-492025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study does not plan to share individual participant data. The collected data contain identifiable clinical information and cervical cytology results, and the ethics approval does not permit public release of raw participant-level data. Aggregated data may be available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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