AzTrials
AzTrials

Cervical CancerNCT06550583

Screening for Early Cervical Cancer Detection

An observational study of Cervical Cancer and Cervix Neoplasm, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years, women only
Conditions the study is for
Cervical Cancer, Cervix Neoplasm
What is being tested?
Pap smear /Test
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jun 2023to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • Women only
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71111

Other trials in Egypt

About this study

Official title: A Clinical Audit on Screening Program for Early Cervical Cancer Detection.

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.

Read the 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

Being tested
Pap smear /Test
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (1)

  1. Via test

    Via test will be done to all patients come to screening clinic and Adherence to screening program protocol

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start1 Jun 2023
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550583
Sponsor's protocol ID
screening for cervical cancer
Status last verified
Aug 2024
First submitted
5 Aug 2024
Last updated
13 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36584208

  • 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.

    PubMed 35460940

  • 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.

    PubMed 36583290

  • 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.

    PubMed 33449334

  • 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.

    PubMed 36545760

  • 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.

    PubMed 28693017

  • 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.

    PubMed 35804848

  • 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.

    PubMed 35984812

  • 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.

    PubMed 31107987

  • 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.

    PubMed 36311598

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer and Cervix Neoplasm, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Screening clinic in Women & Children Hospital (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06550583, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in