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Completed

NCT Number: NCT07250841

Cervical Intraepithelial Neoplasia Screening Using Liquid-Based Pap Smear 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid-Based Pap Smear (LBC)

Diagnostic Test

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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