Cervix CancerNCT06641531
Prevalence of Abnormal Pap Smear
An observational study of Cervix Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- Screening pap smear test
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Non pregnant sexually active women aged from 21 to 60 years old.
Who may be able to join
- Non pregnant sexually active women aged from 21 to 60 years old.
- Patients who didn't have their pap smear done in last 3 years .
- Patient who had previous abnormal pap smear and coming for follow up.
Who cannot join
- Women who were diagnosed cervical cancer that was treated.
- Women who underwent total hysterectomy.
- Women who are pregnant.
- Patients whose pap smear was done in last 3 years with reassuring results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Sohag University
Sohag
Mostafa redwan, master, 0101374970, mostafa_redwan_post@med.sohag.edu.eg
About this study
Official title: Prevalence of Abnormal Pap Smear in Sohag University Hospital Outpatient Clinic
This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
Read the detailed description
This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending Sohag university hospital outpatient clinic. Participating women will be subjected to accurate history taking regarding age, parity, Body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients.
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain . The Bethesda System will be used for cytological interpretation.
- Conditions
- Cervix Cancer
- Being tested
- Screening 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.
Screening pap smear testOther
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain
| Study group | Role | What they receive |
|---|---|---|
| Normal group | normal pap smear Receives: Other: Screening pap smear test | |
| Abnormal group | Abnormal routine Pap smears will be classified according to latest Bethesda system into the following categories : Atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells cannot exclude high grade squamous intraepithelial lesion (ASC-H), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma (SCC), atypical glandular cells of undetermined significance (AGUS), and adenocarcinoma (ADC). Receives: Other: Screening pap smear test |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
Measured: From October 2024 to April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Elsayed Radwan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641531
- Sponsor's protocol ID
- Soh-Med-24-09-13MS
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Abnormal Pap Smear in Sohag University Hospital Outpatient Clinic
- ClinicalTrials.gov ID
- NCT06641531
- Acronym / sponsor ID
- Soh-Med-24-09-13MS
- Conditions
- Cervix Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
Detailed description
This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending Sohag university hospital outpatient clinic. Participating women will be subjected to accurate history taking regarding age, parity, Body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients.
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain . The Bethesda System will be used for cytological interpretation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Other: Screening pap smear testnormal pap smear |
| Abnormal group | – | Other: Screening pap smear testAbnormal routine Pap smears will be classified according to latest Bethesda system into the following categories : Atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells cannot exclude high grade squamous intraepithelial lesion (ASC-H), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma (SCC), atypical glandular cells of undetermined significance (AGUS), and adenocarcinoma (ADC). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Non pregnant sexually active women aged from 21 to 60 years old.
Key inclusion criteria (3 listed)
- Non pregnant sexually active women aged from 21 to 60 years old.
- Patients who didn't have their pap smear done in last 3 years .
- Patient who had previous abnormal pap smear and coming for follow up.
Key exclusion criteria (4 listed)
- Women who were diagnosed cervical cancer that was treated.
- Women who underwent total hysterectomy.
- Women who are pregnant.
- Patients whose pap smear was done in last 3 years with reassuring results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening pap smear testThe patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted. The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain | Other | Abnormal group, Normal group |
Primary outcome
number of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
Time frame: From October 2024 to April 2025
to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix Cancer, run by Sohag 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: looking for participants now, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa radwan, Master (01013774970, mostafa_redwan_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic. (time frame: From October 2024 to April 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.