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

NCT07250841 — Completed, 984 participants, Kasr El Aini Hospital

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

RegistryNCT07250841
StatusCompleted
Study typeObservational
Enrollment984 (Actual)
SponsorKasr El Aini Hospital (Other)
ConditionsCervical Intraepithelial Neoplasia, Cervical Cancer (Early Detection)
InterventionsLiquid-Based Pap Smear (LBC) (Diagnostic test)
Datesstart 2024-09-01, primary completion 2025-03-01, completion 2025-03-01, first posted 2025-11-26, last updated 2025-11-28
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Cervical Intraepithelial Neoplasia All trials for Cervical Cancer (Early Detection) All trials of Liquid-Based Pap Smear (LBC)

-Summary

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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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Gynecological ScreeningDiagnostic Test: Liquid-Based Pap Smear (LBC)Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics who undergo liquid-based Pap smear screening for detection of cervical intraepithelial neoplasia.
  • 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.

+Outcome measures

Primary outcomes

  • Detection of Cervical Cytological Abnormalities [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

  • Prevalence of Abnormal Cervical Cytology [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
  • Correlation Between Participant Characteristics and Abnormal Cytology [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)

+Eligibility

Sex: Female, ages: 25 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Kasr Al-Aini Hospital - Cairo UniversityCairoEgypt

+Investigators