Cervical Intraepithelial Neoplasia Screening by Liquid-Based Pap Smear in General Gynecological Services Among Egyptian Women
| Registry | NCT07250841 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 984 (Actual) |
| Sponsor | Kasr El Aini Hospital (Other) |
| Conditions | Cervical Intraepithelial Neoplasia, Cervical Cancer (Early Detection) |
| Interventions | Liquid-Based Pap Smear (LBC) (Diagnostic test) |
| Dates | start 2024-09-01, primary completion 2025-03-01, completion 2025-03-01, first posted 2025-11-26, last updated 2025-11-28 |
| Locations | 1 site in Egypt |
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All trials for Cervical Intraepithelial Neoplasia All trials for Cervical Cancer (Early Detection) All trials of Liquid-Based Pap Smear (LBC)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Gynecological Screening | Diagnostic 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kasr Al-Aini Hospital - Cairo University | Cairo | Egypt |