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临床试验/NCT07250841
NCT07250841已完成不适用

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

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 984 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
984
试验地点
1
主要终点
Detection of Cervical Cytological Abnormalities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Detection of Cervical Cytological Abnormalities

时间窗: 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).

次要结局

  • Prevalence of Abnormal Cervical Cytology(At time of screening)
  • Correlation Between Participant Characteristics and Abnormal Cytology(At time of screening)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Abdelhamid Ahmed Abdelmaksoud

Obstetrics and Gynecology Resident

Kasr El Aini Hospital

研究点 (1)

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