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NCT07897786Not yet recruiting

Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit

Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit: Prospective Evaluation of the Screening Pathway From Pap Smear to Definitive Management

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
20 Oct 2026
Start date
1 Nov 2026
Primary completion date
30 Nov 2027
Lead sponsor
Assiut University
NCT number
NCT07897786

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 1 Nov 2026 to the primary completion date, 30 Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Refusal to participate in the study.
  • Transfer of clinical care to another healthcare facility where sufficient outcome and follow-up information cannot be obtained.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.