Screening for Early Cervical Cancer Detection

NCT ID: NCT06550583

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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

Conditions

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Cervical Cancer Cervix Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Pap smear /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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mostafa Abdelraof Soliman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed M Soliman, physician

Role: STUDY_CHAIR

Assiut University

Hisham A Alsayed Abotaleb, professor

Role: STUDY_DIRECTOR

Assiut University

Hazem S Eldeen Mohammed, professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 36584208 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 35460940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36583290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33449334 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 36545760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28693017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35804848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35984812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31107987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36311598 (View on PubMed)

Other Identifiers

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screening for cervical cancer

Identifier Type: -

Identifier Source: org_study_id

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