A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening

Официальное название

A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening

Обзор

The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study. The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining. In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.

Вмешательства

• Диагностический тест Detection of Cervical Lesions by Fluorescence Photoelectric Image
  Photoelectric detection was carried out on the subjects of the experimental group.

Первичные конечные точки

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

Вторичные конечные точки (1)

• The correlation between fluorescence photoelectric technology and HPV detection and cytology results. [Срок оценки: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.]

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
• 2\. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
• 3\. Fully informed and agreed to participate in the study.
• 4\. No history of cervical cancer disease and cancer in other parts.

Критерии исключения

• 1\. Cannot meet all Inclusion Criteria.
• 2\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
• 3\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Китай · 1 центр

• Lei Li — Пекин

Идентификаторы

NCT: NCT06491888 · OITS2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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