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Набор скоро начнётся NCT07692919

VIA Versus Colposcopy

Наблюдательное Cervical Intraepithelial Neoplasia (CIN) Cervicitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VIA.
Кому может быть актуально
Состояния в реестре: Cervical Intraepithelial Neoplasia (CIN), Cervicitis. Базовые параметры: 25 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

  • VIA Versus Colposcopy in terms of in terms of sensitivity and specificity [Срок оценки: 2 weeks]
  • sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women [Срок оценки: From enrollment to the the result at 14 days]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07692919 · Soh-Med-26-6-23MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗