Cervical Intraepithelial NeoplasiaNCT07897786
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
An observational study of Cervical Intraepithelial Neoplasia and Uterine Cervical Neoplasms, run by Assiut University.
Trial summary
Cervical cancer is largely preventable when precancerous changes are detected and treated early. However, an effective screening program requires not only collecting a screening test, but also ensuring seamless continuity across the entire care pathway, including adequate specimen collection, accurate laboratory… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms, Cervical Precancerous Lesions
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Adult, Older adult
Study population: The study population comprises women attending the Early Cancer Detection Unit at Women's Health Hospital, Assiut University, who are eligible for cervical cytology (Pap smear) screening according to the unit's clinical guidelines during the one-year study period. Participants include women presenting for routine cervical screening or clinical evaluation who consent to prospective follow-up across the screening, referral, diagnostic (colposcopy and biopsy), and definitive management pathway.
Who may be able to join
- Women attending the Early Cancer Detection Unit who are eligible for cervical cytology (Pap smear) according to institutional screening policy.
- Willingness and ability to provide written informed consent to participate.
- Feasibility of prospective documentation of screening, referral, diagnostic, treatment, and follow-up data.
- Women with abnormal cytology who require further clinical assessment and agree to be followed through the clinical pathway until definitive management or study completion.
Who cannot join
- Refusal to participate in the study.
- Prior history or confirmed diagnosis of invasive cervical cancer at the time of enrollment.
- Previous total hysterectomy with complete removal of the cervix where cervical cancer screening is not clinically indicated.
- Transfer of clinical care to another healthcare facility where sufficient outcome and follow-up information cannot be obtained.
About this study
Official title: Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit: Prospective Evaluation of the Screening Pathway From Pap Smear to Definitive Management
Cervical cancer is largely preventable when precancerous changes are detected and treated early. However, an effective screening program requires not only collecting a screening test, but also ensuring seamless continuity across the entire care pathway, including adequate specimen collection, accurate laboratory reporting, prompt referral, timely colposcopy, biopsy confirmation, treatment, and follow-up. Delays or breakdowns at any stage can increase the risk of disease progression.
This prospective observational clinical audit aims to evaluate the quality, timeliness, and continuity of cervical cytology services at the Early Cancer Detection Unit, Women's Health Hospital, Assiut University.
Read more
Women attending the unit who are eligible for cervical screening will be invited to participate. Because this is an observational audit of standard healthcare services, all examinations, tests, and treatments (such as Pap smears, colposcopies, cervical biopsies, and excisional or ablative therapies) are performed strictly according to routine clinical indications and standard management guidelines. No experimental interventions or tests will be administered.
The study will prospectively monitor participants along the clinical pathway to evaluate:
- The rate of adequate Pap smear specimens and distribution of cytological findings.
- Time intervals between screening, cytology results, specialty referral, colposcopy examination, histopathological diagnosis, and definitive treatment.
- Rates of completed referrals, colposcopy appointments, biopsy confirmations, and definitive treatments.
- Reasons for delayed appointments, missed visits, or loss to follow-up through clinical record reviews and routine patient contact.
The findings will help identify patient, provider, and health-system factors contributing to care gaps, providing evidence-based quality indicators to enhance the efficiency and clinical performance of cervical screening services.
- Conditions
- Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms, Cervical Precancerous Lesions, Cervical Dysplasia
- Keywords
- Pap smear, Cervical cytology, Clinical audit, Colposcopy, Screening pathway, Quality improvement, Bethesda system
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cytology Screening and Follow-up Cohort | Eligible women attending the Early Cancer Detection Unit who undergo routine cervical cytology (Pap smear) screening. Participants are prospectively evaluated across the screening and clinical management pathway. Women with abnormal cytological results are followed through subsequent referral, colposcopic evaluation, cervical biopsy/histopathological assessment (when clinically indicated), definitive therapeutic management (excisional or ablative procedures), and follow-up according to standard clinical protocols and ASCCP guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cervical Cytology Specimen Adequacy
The percentage of Pap smear specimens categorized as "satisfactory for evaluation" according to The Bethesda System for Reporting Cervical Cytology criteria (demonstrating adequate squamous cellularity and cellular preservation). Unsatisfactory specimens (e.g., due to insufficient cellularity, obscuring blood, or intense inflammation) will be documented.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelos Alkes Ghobrial Hakim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897786
- Sponsor's protocol ID
- Cervical Cytology Audit
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit: Prospective Evaluation of the Screening Pathway From Pap Smear to Definitive Management
- ClinicalTrials.gov ID
- NCT07897786
- Acronym / sponsor ID
- Cervical Cytology Audit
- Conditions
- Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms, Cervical Precancerous Lesions, Cervical Dysplasia
- Keywords
- Pap smear, Cervical cytology, Clinical audit, Colposcopy, Screening pathway, Quality improvement, Bethesda system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Cervical cancer is largely preventable when precancerous changes are detected and treated early. However, an effective screening program requires not only collecting a screening test, but also ensuring seamless continuity across the entire care pathway, including adequate specimen collection, accurate laboratory reporting, prompt referral, timely colposcopy, biopsy confirmation, treatment, and follow-up. Delays or breakdowns at any stage can increase the risk of disease progression.
This prospective observational clinical audit aims to evaluate the quality, timeliness, and continuity of cervical cytology services at the Early Cancer Detection Unit, Women's Health Hospital, Assiut University.
Women attending the unit who are eligible for cervical screening will be invited to participate. Because this is an observational audit of standard healthcare services, all examinations, tests, and treatments (such as Pap smears, colposcopies, cervical biopsies, and excisional or ablative therapies) are performed strictly according to routine clinical indications and standard management guidelines. No experimental interventions or tests will be administered.
The study will prospectively monitor participants along the clinical pathway to evaluate:
- The rate of adequate Pap smear specimens and distribution of cytological findings.
- Time intervals between screening, cytology results, specialty referral, colposcopy examination, histopathological diagnosis, and definitive treatment.
- Rates of completed referrals, colposcopy appointments, biopsy confirmations, and definitive treatments.
- Reasons for delayed appointments, missed visits, or loss to follow-up through clinical record reviews and routine patient contact.
The findings will help identify patient, provider, and health-system factors contributing to care gaps, providing evidence-based quality indicators to enhance the efficiency and clinical performance of cervical screening services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Cytology Screening and Follow-up Cohort | – | –Eligible women attending the Early Cancer Detection Unit who undergo routine cervical cytology (Pap smear) screening. Participants are prospectively evaluated across the screening and clinical management pathway. Women with abnormal cytological results are followed through subsequent referral, colposcopic evaluation, cervical biopsy/histopathological assessment (when clinically indicated), definitive therapeutic management (excisional or ablative procedures), and follow-up according to standard clinical protocols and ASCCP guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study population comprises women attending the Early Cancer Detection Unit at Women's Health Hospital, Assiut University, who are eligible for cervical cytology (Pap smear) screening according to the unit's clinical guidelines during the one-year study period. Participants include women presenting for routine cervical screening or clinical evaluation who consent to prospective follow-up across the screening, referral, diagnostic (colposcopy and biopsy), and definitive management pathway.
Key inclusion criteria (4 listed)
- Women attending the Early Cancer Detection Unit who are eligible for cervical cytology (Pap smear) according to institutional screening policy.
- Willingness and ability to provide written informed consent to participate.
- Feasibility of prospective documentation of screening, referral, diagnostic, treatment, and follow-up data.
- Women with abnormal cytology who require further clinical assessment and agree to be followed through the clinical pathway until definitive management or study completion.
Key exclusion criteria (4 listed)
- Refusal to participate in the study.
- Prior history or confirmed diagnosis of invasive cervical cancer at the time of enrollment.
- Previous total hysterectomy with complete removal of the cervix where cervical cancer screening is not clinically indicated.
- Transfer of clinical care to another healthcare facility where sufficient outcome and follow-up information cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Cervical Cytology Specimen Adequacy
Time frame: Up to 4 weeks
The percentage of Pap smear specimens categorized as "satisfactory for evaluation" according to The Bethesda System for Reporting Cervical Cytology criteria (demonstrating adequate squamous cellularity and cellular preservation). Unsatisfactory specimens (e.g., due to insufficient cellularity, obscuring blood, or intense inflammation) will be documented.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Uterine Cervical Neoplasms, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Cervical Cytology Specimen Adequacy (time frame: Up to 4 weeks). 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 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.