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

NCT ID: NCT07250841

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 984 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-01

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer (Early Detection)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Liquid-Based Pap Smear (LBC)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tamer Abdelhamid Ahmed Abdelmaksoud

Obstetrics and Gynecology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M El-Minawi, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Yossra Lasheen, Assistant Professor

Role: STUDY_CHAIR

Cairo University

Mohamed Aly, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Locations

Kasr Al-Aini Hospital - Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-492025

Identifier Type: -

Identifier Source: org_study_id