Cervical Intraepithelial NeoplasiaNCT07250841
Cervical Intraepithelial Neoplasia Screening Using Liquid-Based Pap Smear Among Egyptian Women
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer (Early Detection), run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer (Early Detection)
- What is being tested?
- Liquid-Based Pap Smear (LBC)
- How many people
- 984 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics and undergoing routine cervical screening using liquid-based cytology.
Who may be able to join
- Females aged 25-60
- Attending Kasr Al-Aini outpatient gynecology clinics
- Willing to provide informed consent
Who cannot join
- • Pregnancy
- Prior hysterectomy
- Existing cervical lesions
- Previous CIN treatment in last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Intraepithelial Neoplasia Screening by Liquid-Based Pap Smear in General Gynecological Services Among Egyptian Women
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.
Read the 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.
- Being tested
- Liquid-Based Pap Smear (LBC)
- Keywords
- Liquid-Based Cytology, Pap Smear, Cervical Screening, HPV, CIN, Cervical Dysplasia, Bethesda System, Gynecological Screening, Egypt
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Liquid-Based Pap Smear (LBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At time of screening (single visit)
Secondary outcomes (2)
Prevalence of Abnormal Cervical Cytology
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
Measured: At time of screening
Correlation Between Participant Characteristics and Abnormal Cytology
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)
Measured: At time of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abdelhamid Ahmed Abdelmaksoud, Kasr El Aini Hospital
- Investigators
- Ahmed M El-Minawi, Professor, Principal investigator, Cairo UniversityYossra Lasheen, Assistant Professor, Study chair, Cairo UniversityMohamed Aly, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250841
- Sponsor's protocol ID
- MS-492025
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not plan to share individual participant data. The collected data contain identifiable clinical information and cervical cytology results, and the ethics approval does not permit public release of raw participant-level data. Aggregated data may be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Intraepithelial Neoplasia Screening by Liquid-Based Pap Smear in General Gynecological Services Among Egyptian Women
- ClinicalTrials.gov ID
- NCT07250841
- Acronym / sponsor ID
- MS-492025
- Keywords
- Liquid-Based Cytology, Pap Smear, Cervical Screening, HPV, CIN, Cervical Dysplasia, Bethesda System, Gynecological Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 25-60 attending Kasr Al-Aini outpatient gynecology clinics and undergoing routine cervical screening using liquid-based cytology.
Key inclusion criteria (3 listed)
- Females aged 25-60
- Attending Kasr Al-Aini outpatient gynecology clinics
- Willing to provide informed consent
Key exclusion criteria (4 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Gynecological Screening |
Primary outcome
Detection of Cervical Cytological Abnormalities
Time frame: 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).
2 secondary outcomes
Prevalence of Abnormal Cervical Cytology
Time frame: At time of screening
Correlation Between Participant Characteristics and Abnormal Cytology
Time frame: At time of screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. The study does not plan to share individual participant data. The collected data contain identifiable clinical information and cervical cytology results, and the ethics approval does not permit public release of raw participant-level data. Aggregated data may be available upon reasonable request.
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Exploratory Study of the Efficacy of HAL-PDT in CIN 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M El-Minawi, Professor principal investigator
Cairo University
Yossra Lasheen, Assistant Professor study chair
Cairo University
Mohamed Aly, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer (Early Detection), run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Cervical Cytological Abnormalities (time frame: At time of screening (single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.