An observational study in Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms and Cervical Precancerous Lesions, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Assiut University · Observational
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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 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.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's planned enrollment of 500 is above the median of 435 across 110 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Up to 4 weeks
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 44 observational studies under Uterine Cervical Dysplasia, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 30. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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