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

NCT07250841 | Completed

• 1 other identifier: MS-492025
• Study Type: observational
• Target: 984
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer (Early Detection)

Keywords

Liquid-Based Cytology; Pap Smear; Cervical Screening; HPV; CIN; Cervical Dysplasia; Bethesda System; Gynecological Screening; Egypt

Outcome Measures

Primary Outcomes (1)

• Detection of Cervical Cytological Abnormalities

  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).

  At time of screening (single visit)

Secondary Outcomes (2)

• Prevalence of Abnormal Cervical Cytology

  At time of screening

• Correlation Between Participant Characteristics and Abnormal Cytology

  At time of screening

Study Arms (1)

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.

Diagnostic Test: Liquid-Based Pap Smear (LBC)

Interventions

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.

Gynecological Screening

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: Only individuals who self-identify as female are eligible to participate, as the study involves cervical cytology screening and requires the presence of a cervix.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics and undergoing routine cervical screening using liquid-based cytology.

You may qualify if:

• Females aged 25-60
• Attending Kasr Al-Aini outpatient gynecology clinics
• Willing to provide informed consent

You may not qualify if:

• Pregnancy
• Prior hysterectomy
• Existing cervical lesions
• Previous CIN treatment in last 5 years

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al-Aini Hospital - Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Ahmed M El-Minawi, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Yossra Lasheen, Assistant Professor

  Cairo University

  STUDY CHAIR

• Mohamed Aly, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology Resident

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)