Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Официальное название

A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus

Обзор

For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

Подробное описание

For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

Вмешательства

• Процедура diagnostic cervical conization
  For the patients who met the inclusion criteria, the gynecologists perform cervical conization and pathological examinations. Then the patients will be followed-up for at least two years with the tests of cervical TCT \& HPV, and colposcopy if necessary. The data will be analyzed and see if the patients with high risk factors benefit from the surgery or not.

Первичные конечные точки

• The incidence of discovering concealed cervical cancer or percancerous lesions [Срок оценки: up to 2 months after recruited]
• The incidence of HPV clearance after the cervical conization [Срок оценки: Through the study completion, an average of 3~5 years]

Критерии участия

Критерии включения

• The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.
• The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:

• The course of HPV type 16/18 persistent infection is more than two years.
• The integration reads of HPV is more than 15.
• The impression of colposcopy indicates precancerous lesions.
• The cervical TCT indicates ASC-H/HSIL/SCC/AGC-FN/AIS/AC.

Критерии исключения

• Pregnant women.
• Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.
• The patients are suffering malignant tumors of other system and have not been cured.
• There is acute inflammation of the lower genital or anal tract.
• The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and — Ухань

Идентификаторы

NCT: NCT05510830 · TJ-IRB20220769

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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