Regression of Cervical Precancerous Lesions and Associated Risk Factors
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: Colposcopy.
- Кому может быть актуально
- Состояния в реестре: Cervix Uteri SIL, HPV, CIN2, CIN3. Базовые параметры: 18 лет — 40 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
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The aim of this study is to assess the extent of histopathological regression of severe cervical precancerous lesions (CIN 2 and CIN 3); evaluate the proportion of patients who experience the normalization of HPV test and cytology finding among those who were treated conservatively and those who underwent conization; and identify predictive parameters associated with regression. Based on this analysis, a model will be proposed to predict the likelihood of lesion regression.
Подробное описание
Introduction There are three grades of dysplasia of the cervix based on their severity (CIN 1-3). Most women with CIN 2 or CIN 3 (high-grade - HG lesions) are referred for conization due to the presumed risk of developing invasive cervical cancer. However, this surgical intervention is associated with an increased risk of preterm labor in the future.
From the literature, it is evident that 30% - 60% of CIN 2 and CIN 3 lesions spontaneously regress. Colposcopic examination is a tool that can accurately assess the severity of the lesion and safely evaluate the dynamics of its development. It can be used to exclude the presence of invasive cervical cancer.
The aim of the study is to determine the absolute rate of spontaneous regression of HG lesions, considering stratification factors.
Methods Patients meeting all inclusion criteria and none of the exclusion criteria are included (see below). Colposcopic evaluations occur at four-month intervals during the study. In case of progression, the patient is indicated for conization; in case of persistence, the patient is consulted and can choose further observation or conization; in case of regression, punch biopsy is performed to acquire a histopathologic sample for primary endpoint evaluation. The biopsy/conization result is subsequently compared with the initial sample to declare regression or persistence of the HG lesion.
The HPV status and cytological findings are evaluated similarly. Stratification criteria such as age, colposcopic characteristics, HPV genotype (Cobas 4800, Roche Molecular Systems, Pleasanton, USA), methylation markers (GynTect®, Oncgnostics GmbH, Löbstedter Str. 41, 07749 Jena, Germany), semiquantitative microscopic assessment of the vaginal swab, and personal history are assessed during monitoring.
Вмешательства
- Диагностический тест Colposcopy
No surgery, observation
Первичные конечные точки
- Regression-rate of severe cervical precancerous lesions (CIN 2 and CIN 3) expressed through a comparison of initial and final histology [Срок оценки: 3 years]
Вторичные конечные точки (4)
- Rate of HPV negativization in patients with spontaneous regression compared to patients with persistence after conization [Срок оценки: 3 years]
- Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization [Срок оценки: 3 years]
- Regression-rate considering specified stratification factors [Срок оценки: 3 years]
- Development of a model for predicting spontaneous regression [Срок оценки: 3 years]
Критерии участия
Критерии включения
- squamocolumnar junction fully visualized
- bioptically verified CIN 2 or CIN 3
- age ≥ 18 years
- age ≤ 40 years
- informed consent
Критерии исключения
- squamocolumnar junction not fully visualized
- suspicion on glandular lesion
- suspicion on invasive cancer
- personal history of CIN 2, 3 or cerv. cancer
- gravidity
- HIV positivity
- immunosuppression
- impossible photographic documentation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Чехия · 1 центр
- General University Hospital — Prague
Публикации
- Dostalek L, Brynda D, Marek R, Hederlingova J, Tripac I, Nemejcova K, Slovackova M, Zima T, Cibula D, Slama J. Regression of high-grade squamous intraepithelial cervical lesions and associated risk factors (RECER). Int J Gynecol Cancer. 2025 May;35(5):101768. doi: 10.1016/j.ijgc.2025.101768. Epub 2025 Mar 13. PMID 40215795
Идентификаторы
NCT: NCT06147388 · 154/22 S