- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550583
Screening for Early Cervical Cancer Detection
A Clinical Audit on Screening Program for Early Cervical Cancer Detection.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71111
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Screening clinic in Women & Children Hospital
Time Frame: Baseline
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All women undergo Pap smear test according to inclusion criteria and will be adherence to screening program protocol
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Via test
Time Frame: baseline
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Via test will be done to all patients come to screening clinic and Adherence to screening program protocol
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed M Soliman, physician, Assiut University
- Study Director: Hisham A Alsayed Abotaleb, professor, Assiut University
- Study Director: Hazem S Eldeen Mohammed, professor, Assiut University
Publications and helpful links
General Publications
- 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.
- Attallah O. Cervical cancer diagnosis based on multi-domain features using deep learning enhanced by handcrafted descriptors. Applied Sciences. 2023;13(3):1916.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- screening for cervical cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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