NCT06550583

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 5, 2024

Last Update Submit

August 8, 2024

Conditions

Cervical CancerCervix Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Screening clinic in Women & Children Hospital

    All women undergo Pap smear test according to inclusion criteria and will be adherence to screening program protocol

    Baseline

Secondary Outcomes (1)

  • Via test

    baseline

Interventions

Pap smear /TestDIAGNOSTIC_TEST

Patients will be placed in the lithotomy position, and a sterile bivalve speculum will be inserted into the vagina. • A sample will be taken from the ectocervix by rotating a wooden Ayre spatula 360°. The sample will be quickly smeared onto a labeled glass slide and fixed with 95% ethyl alcohol in a jar to be sent to the Department of Pathology for cytopathological examination

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssexually active women in reproductive age .
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients who will attend gynecology clinics at Women \& Children Hospital in reproductive age in (Assuit) Egypt

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (12)

  • Amado G, Weldegebreal F, Birhanu S, Dessie Y. Cervical cancer screening practices and its associated factors among females of reproductive age in Durame town, Southern Ethiopia. PLoS One. 2022 Dec 30;17(12):e0279870. doi: 10.1371/journal.pone.0279870. eCollection 2022.

    PMID: 36584208BACKGROUND

  • Attallah O. Cervical cancer diagnosis based on multi-domain features using deep learning enhanced by handcrafted descriptors. Applied Sciences. 2023;13(3):1916.

    BACKGROUND

  • Burmeister CA, Khan SF, Schafer G, Mbatani N, Adams T, Moodley J, Prince S. Cervical cancer therapies: Current challenges and future perspectives. Tumour Virus Res. 2022 Jun;13:200238. doi: 10.1016/j.tvr.2022.200238. Epub 2022 Apr 20.

    PMID: 35460940BACKGROUND

  • Hakimi S, Lami F, Allahqoli L, Alkatout I. Barriers to the HPV vaccination program in the Eastern Mediterranean region: a narrative review. J Turk Ger Gynecol Assoc. 2023 Mar 15;24(1):48-56. doi: 10.4274/jtgga.galenos.2022.2022-6-6. Epub 2022 Dec 30.

    PMID: 36583290BACKGROUND

  • Haran M, Kelly JR, Kennedy L, Hennigan K, Farid H, Herteu C, Kreisel A, Salehin S, O' Sullivan M, Keating S, Ivers JH, Scully M. An audit of the cervical screening programme in the National Drug Treatment Centre (NDTC). Ir J Med Sci. 2021 Nov;190(4):1379-1386. doi: 10.1007/s11845-020-02459-1. Epub 2021 Jan 15.

    PMID: 33449334BACKGROUND

  • Mohammed MS, Sand AS, Hassuna NA. Prevalence of HPV 16 and HPV 18 in cervical cancer in Minia Governorate. Egyptian Journal of Medical Microbiology. 2020;29(4):57-63.

    BACKGROUND

  • Momenimovahed Z, Mazidimoradi A, Maroofi P, Allahqoli L, Salehiniya H, Alkatout I. Global, regional and national burden, incidence, and mortality of cervical cancer. Cancer Rep (Hoboken). 2023 Mar;6(3):e1756. doi: 10.1002/cnr2.1756. Epub 2022 Dec 21.

    PMID: 36545760BACKGROUND

  • Nayar R, Wilbur DC. The Bethesda System for Reporting Cervical Cytology: A Historical Perspective. Acta Cytol. 2017;61(4-5):359-372. doi: 10.1159/000477556. Epub 2017 Jul 11.

    PMID: 28693017BACKGROUND

  • Nilima N, Mani K, Kaushik S, Rai SN. Cervical Cancer Screening and Associated Barriers among Women in India: A Generalized Structural Equation Modeling Approach. Cancers (Basel). 2022 Jun 23;14(13):3076. doi: 10.3390/cancers14133076.

    PMID: 35804848BACKGROUND

  • Romli R, Abd Rahman R, Chew KT, Mohd Hashim S, Mohamad EMW, Mohammed Nawi A. Empirical investigation of e-health intervention in cervical cancer screening: A systematic literature review. PLoS One. 2022 Aug 19;17(8):e0273375. doi: 10.1371/journal.pone.0273375. eCollection 2022.

    PMID: 35984812BACKGROUND

  • Wang J, Elfstrom KM, Andrae B, Nordqvist Kleppe S, Ploner A, Lei J, Dillner J, Sundstrom K, Sparen P. Cervical cancer case-control audit: Results from routine evaluation of a nationwide cervical screening program. Int J Cancer. 2020 Mar 1;146(5):1230-1240. doi: 10.1002/ijc.32416. Epub 2019 Jun 3.

    PMID: 31107987BACKGROUND

  • Zhu J, Ge Z, Xia J, Liu Q, Ran Q, Yang Y. Status quo and problem analysis of cervical cancer screening program in China: Based on RE-AIM framework. Front Public Health. 2022 Oct 14;10:987787. doi: 10.3389/fpubh.2022.987787. eCollection 2022.

    PMID: 36311598BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pap smear test results

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mohamed M Soliman, physician

    Assiut University

    STUDY CHAIR

  • Hisham A Alsayed Abotaleb, professor

    Assiut University

    STUDY DIRECTOR

  • Hazem S Eldeen Mohammed, professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 13, 2024

Study Start

June 1, 2023

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

EG(1)