Clinical trial NCT06550583: Screening for Early Cervical Cancer Detection
Official title: A Clinical Audit on Screening Program for Early Cervical Cancer Detection.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Cancer
Cervix Neoplasm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients who will attend gynecology clinics at Women \& Children Hospital in reproductive age in (Assuit) Egypt

Brief summary: This study is to audit results and adherence to Cervical Screening program before and after the implementing awareness of the WHO guidelines of screening among the multidisciplinary healthcare workers and patients.

Detailed description: Cervical cancer screening is the asymptomatic detection of pre-cancer and cancer in women at risk, with at least one screening suggested for women aged 30-49 years. According to the World Health Survey (2015), 19% of eligible women in developing countries and 63% of those in developed nations had their cervical cancer screening done using a Pap smear or visual inspection with acetic acid (VIA).

According to latest estimates by World Health Organization (WHO), in Egypt, 866 women are diagnosed with cervical cancer every year and 373 die from the disease. Cervical cancer is the 13th most common cancer in women in Egypt and the 10th most common cancer in women aged between 15 to 44 years . Statistics from Egyptian studies provide pre invasive cervical lesion incidence levels of 0.3 % to 0.5 % .

The human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. HPV can be transmitted through sexual contact, including vaginal or oral sex with an infected person. HPV has more than 100 strains, of which HPV16 and HPV18 account for about 70% of invasive cervical cancers

Eligibility criteria: Inclusion Criteria:

* Women 20-60 years.

  * Sexually active.
  * Fulfilling Cervical Check's eligibility criteria for screening at the time of the audit https://www.cervicalcheck.ie/_fileupload/File/Eligibility%20Framework.pdf

Exclusion Criteria:

Patient who had underwent to total hysterectomy.

* Pregnant or postpartum or post abortive patients
* Patient having any history of treatment for cervical dysplasia.
* Immunocompromised patients.

Primary outcomes:
measure: Screening clinic in Women & Children Hospital
timeFrame: Baseline
Secondary outcomes:
measure: Via test
timeFrame: baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mohamed M Soliman, physician
role: STUDY_CHAIR
affiliation: Assiut University
name: Hisham A Alsayed Abotaleb, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hazem S Eldeen Mohammed, professor
role: STUDY_DIRECTOR
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