Effect of HPV Integration on Prognosis of Young Women With CIN2 in China

Официальное название

Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China

Обзор

Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science \& Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.

Подробное описание

This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.

Вмешательства

• Другое Follow up
  Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.

Первичные конечные точки

• Cervical histopathology testing at baseline [Срок оценки: Baseline]
• Cervical histopathology testing at 6-month follow-up [Срок оценки: 6-month follow-up]
• Cervical histopathology testing at 12-month follow-up [Срок оценки: 12-month follow-up]
• Human Papillomavirus (HPV) viral integration test at baseline [Срок оценки: Baseline]
• Human Papillomavirus (HPV) viral integration test at 6-month follow-up [Срок оценки: 6-month follow-up]
• Human Papillomavirus (HPV) viral integration test at 12-month follow-up [Срок оценки: 12-month follow-up]
• Cervical cytology testing at baseline [Срок оценки: Baseline]
• Cervical cytology testing at 3-month follow-up [Срок оценки: 3-month follow-up]
• Cervical cytology testing at 6-month follow-up [Срок оценки: 6-month follow-up]
• Cervical cytology testing at 9-month follow-up [Срок оценки: 9-month follow-up]

Критерии участия

Критерии включения

• Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;
• Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;
• The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;
• Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;
• Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.

Критерии исключения

• Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;
• Pregnant or lactating;
• History of malignant reproductive tract tumors;
• History of hysterectomy, cervical surgery, or pelvic radiation therapy;
• Physical therapy to the cervix within 24 months prior to enrollment;
• The subject has a severe immune system disease that is active;
• Long-term use of contraceptives within 12 months prior to enrollment;
• Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);
• Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);
• Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);
• Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 20 центров

• Fujian Maternity and Child Health Hospital — Фучжоу
• Fujian Medical University Union Hospital — Фучжоу
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Longyan First Hospital — Longyan
• The Second Hospital of Longyan — Longyan
• Ningde Municipal Hospital of Ningde Normal University — Ningde
• The First Hospital of Putian City — Putian
• The Affiliated Hospital of Putian University — Putian
• … и ещё 12 центров

Публикации

• Zhang Y, Zhang Y, Hu T, Pu X, Dong B, Tuo X, Zou H, Zhang W, Lyu Q, Huang W, Xue H, Xu S, Osafo KS, Ren Y, Lin W, Su J, Huang X, Sun P. Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study. BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863. PMID 40295124

Идентификаторы

NCT: NCT05282095 · HPVZHCIN22021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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