Cervical Intraepithelial Neoplasia (CIN)NCT07692919
VIA Versus Colposcopy
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Cervicitis, run by Sohag University.
Trial summary
The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia (CIN), Cervicitis
- What is being tested?
- VIA
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jun 2027
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient clinic pateints
Who may be able to join
- Age from 25 to 65 years.
- Patient undergoing cervical cancer screening using VIA and colposcopy.
- Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
- Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
- Women with Pap smear showing dysplasia.
Who cannot join
- • Pregnant women (if VIA or colposcopy is contraindicated).
- Women with obvious invasive cervical cancer diagnosed previously.
- Women who refuse to provide informed consent or are unable to cooperate with the examination.
- Women having active vaginal bleeding.
- Any past treatment for cervical lesions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia
The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods.
Read the detailed description
Method of study:
Medical and surgical history of the patients will be taken, clinical examinations of the patients will be performed and routine laboratory investigations will be done.
Patients will be asked to empty their bladder and positioned in the lithotomy or dorsal supine position on the examination table. Standard infection control measures will be followed, including hand hygiene and use of sterile gloves and speculum.
Visual Inspection with Acetic Acid (VIA) VIA will be conducted by trained gynecology residents under consultant supervision. A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light. The appearance of acetowhite areas will be considered VIA positive, indicating possible precancerous changes.
Colposcopy Women who are candidate for colposcopy assessment or with abnormal Pap smear will be referred for colposcopic evaluation using a binocular colposcope (magnification: 5×, 10×, and 20×) with a green filter to assess vascular patterns.
Lesions will be scored using the Swede score, an open access validated colposcopic scoring system based on five criteria: uptake of acetic acid, margins and surface, vessels, lesion size, and iodine staining Scores 0-4: normal or low-grade lesion (CIN 1 or less) Scores 5-6: possible high-grade lesion (CIN 2) Scores 7-10: high-grade lesion/CIN 3 or invasive cancer (11). Biopsy and Histopathology Colposcopy-guided biopsies will be performed only in patients with a Swede score ≥ 5, following standard protocols to avoid unnecessary invasive procedures in low-grade lesions. Biopsy specimens will be fixed in 10% formalin, processed, stained with hematoxylin and eosin, and examined under light microscopy.
Histopathological findings will be classified as:
Chronic cervicitis CIN 1, CIN 2, CIN 3 Carcinoma in situ Squamous cell carcinoma (SCC) Adenocarcinoma Classification followed WHO standards (12).
- Being tested
- VIA
- Keywords
- CIN
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIAOther
A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light
What is being measured
The primary outcome is the main question the study is designed to answer.
VIA Versus Colposcopy in terms of in terms of sensitivity and specificity
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.
All patients will be advised on post-procedure care, including avoiding vaginal do
Measured: 2 weeks
sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.
All patients will be advised on post-procedure care, including avoiding vaginal douching, sexual activity, or use of tampons for a few days, if a biopsy will be performed.
Results of the VIA, colposcopy, and histopathology will be explained to the patients, and appropriate follow-up or referral will be arranged for those with CIN 2, CIN 3, or carcinoma.
Patients will be instructed to report any unusual bleeding, pain, or discharge immediately to the clinic.
Measured: From enrollment to the the result at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia (CIN)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassam Mahmoud Abdallah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692919
- Sponsor's protocol ID
- Soh-Med-26-6-23MS
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT07692919
- Acronym / sponsor ID
- Soh-Med-26-6-23MS
- Keywords
- CIN
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods.
Detailed description
Method of study:
Medical and surgical history of the patients will be taken, clinical examinations of the patients will be performed and routine laboratory investigations will be done.
Patients will be asked to empty their bladder and positioned in the lithotomy or dorsal supine position on the examination table. Standard infection control measures will be followed, including hand hygiene and use of sterile gloves and speculum.
Visual Inspection with Acetic Acid (VIA) VIA will be conducted by trained gynecology residents under consultant supervision. A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light. The appearance of acetowhite areas will be considered VIA positive, indicating possible precancerous changes.
Colposcopy Women who are candidate for colposcopy assessment or with abnormal Pap smear will be referred for colposcopic evaluation using a binocular colposcope (magnification: 5×, 10×, and 20×) with a green filter to assess vascular patterns.
Lesions will be scored using the Swede score, an open access validated colposcopic scoring system based on five criteria: uptake of acetic acid, margins and surface, vessels, lesion size, and iodine staining Scores 0-4: normal or low-grade lesion (CIN 1 or less) Scores 5-6: possible high-grade lesion (CIN 2) Scores 7-10: high-grade lesion/CIN 3 or invasive cancer (11). Biopsy and Histopathology Colposcopy-guided biopsies will be performed only in patients with a Swede score ≥ 5, following standard protocols to avoid unnecessary invasive procedures in low-grade lesions. Biopsy specimens will be fixed in 10% formalin, processed, stained with hematoxylin and eosin, and examined under light microscopy.
Histopathological findings will be classified as:
Chronic cervicitis CIN 1, CIN 2, CIN 3 Carcinoma in situ Squamous cell carcinoma (SCC) Adenocarcinoma Classification followed WHO standards (12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic pateints
Key inclusion criteria (5 listed)
- Age from 25 to 65 years.
- Patient undergoing cervical cancer screening using VIA and colposcopy.
- Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
- Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
- Women with Pap smear showing dysplasia.
Key exclusion criteria (5 listed)
- • Pregnant women (if VIA or colposcopy is contraindicated).
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 |
|---|---|---|
| VIAA 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light | Other | – |
Primary outcome
VIA Versus Colposcopy in terms of in terms of sensitivity and specificity
Time frame: 2 weeks
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy. All patients will be advised on post-procedure care, including avoiding vaginal do
sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women
Time frame: From enrollment to the the result at 14 days
Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy. All patients will be advised on post-procedure care, including avoiding vaginal douching, sexual activity, or use of tampons for a few days, if a biopsy will be performed. Results of the VIA, colposcopy, and histopathology will be explained to the patients, and appropriate follow-up or referral will be arranged for those with CIN 2, CIN 3, or carcinoma. Patients will be instructed to report any unusual bleeding, pain, or discharge immediately to the 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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Cervicitis, run by Sohag University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 bassam mahmoud abdallah Mahmoud Abdallah, resident (+201012200274, bmmcamille@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VIA Versus Colposcopy in terms of in terms of sensitivity and specificity (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 9 Jul 2026.