NCT07692919

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

CIN

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    From enrollment to the the result at 14 days

Interventions

VIAOTHER

A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

outpatient clinic pateints

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervicitis

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

bassam mahmoud abdallah Mahmoud Abdallah, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bassam Mahmoud Abdallah Mahmoud

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07