Cervical Cancer (Early Detection), Cervical Intraepithelial Neoplasia
Conditions
Keywords
Liquid-Based Cytology, Pap Smear, Cervical Screening, HPV, CIN, Cervical Dysplasia, Bethesda System, Gynecological Screening, Egypt
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTLiquid-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.
Sponsors
Kasr El Aini Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed