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Набор скоро начнётся NCT06866392

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol

— Наблюдательное Cervical Cancer Cervical Intraepithelial Neoplasia

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: photoelectric detection.
Кому может быть актуально
Состояния в реестре: Cervical Cancer, Cervical Intraepithelial Neoplasia. Базовые параметры: 18 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 →

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Официальное название

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol

Обзор

A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.

Вмешательства

  • Диагностический тест photoelectric detection
    Methylation test and colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results.

Первичные конечные точки

  • Sensitivity and specificity of a photoelectric image detector for cervical lesions [Срок оценки: Enrolled subjects receive histopathological results approximately 7 days after colposcopy]
Вторичные конечные точки (1)
  • Detection rate of CIN2+ by photoelectric cervical lesion image detector [Срок оценки: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.]

Критерии участия

Критерии включения

  • Women between the ages of 18 and 65 who have already had sex life
  • HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
  • No history of cervical cancer and cervical physical therapy, a complete cervix
  • No menstrual period, no sexual activity and vaginal medication within 48 hours
  • The vagina or cervix is not in a stage of acute inflammation
  • Willing to participate in the study with full informed consent

Критерии исключения

  • Cervical dysplasia (congenital malformation or double uterus, etc.)
  • History of cervical treatment (coning, ablation, or photodynamic therapy)
  • There are definite immunosuppression conditions, such as HIV infection or organ transplantation
  • Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
  • A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
  • The patient is in pregnancy or puerperium
  • The other conditions of this study were not considered appropriate by the researchers

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06866392 · CCAZ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗