임상 레이더 AI | ||
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임상시험 NCT05282095은(는) 자궁경부 상피내 종양, HPV 감염, 바이러스 통합, 고등급 편평상피내 병변 (HSIL)에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China 300
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05282095은(는) 자궁경부 상피내 종양, HPV 감염, 바이러스 통합, 고등급 편평상피내 병변 (HSIL)에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2022년 6월 1일에 시작되어 300명의 참여자를 모집하고 있습니다. Fujian Maternity and Child Health Hospital이(가) 진행하며, 2026년 5월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 9월 19일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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 participant...더 보기
공식 제목
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
질환명
자궁경부 상피내 종양HPV 감염바이러스 통합고등급 편평상피내 병변 (HSIL)출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- HPVZHCIN22021
NCT 번호
실제 연구 시작일
2022-06-01
최신 업데이트 게시
2024-09-19
예상 연구 완료일
2026-05-31
계획된 등록 인원
300
연구종류
관찰연구
상태
모집중
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Women aged from 18-45 with histopathologically confirmed CIN2 In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month. | 추적 관찰 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. |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Cervical histopathology testing at baseline | Cervical histopathology was performed at baseline for all participants. | Baseline |
Cervical histopathology testing at 6-month follow-up | Cervical histopathology was performed at 6-month follow-up for all participants. | 6-month follow-up |
Cervical histopathology testing at 12-month follow-up | Cervical histopathology was performed at 12-month follow-up for all participants. | 12-month follow-up |
Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | Baseline |
Human Papillomavirus (HPV) viral integration test at 6-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants. | 6-month follow-up |
Human Papillomavirus (HPV) viral integration test at 12-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants. | 12-month follow-up |
Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline |
Cervical cytology testing at 3-month follow-up | All participants were tested for cervical cytology at 3-month follow-up. | 3-month follow-up |
Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up | 6-month follow-up |
Cervical cytology testing at 9-month follow-up | All participants were tested for cervical cytology at 9-month follow-up | 9-month follow-up |
Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up |
16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline |
16SrRNA sequencing of the vaginal secretions at 3-month follow-up | All participants underwent vaginal secretion sequencing at 3-month follow-up. | 3-month follow-up |
16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up |
16SrRNA sequencing of the vaginal secretions at 9-month follow-up | All participants underwent vaginal secretion sequencing at 9-month follow-up | 9-month follow-up |
16SrRNA sequencing of the vaginal secretions at 12-month follow-up | All participants underwent vaginal secretion sequencing at 12-month follow-up | 12-month follow-up |
Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline |
Human Papillomavirus (HPV) genotyping tests at 3-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up. | 3-month follow-up |
Human Papillomavirus (HPV) genotyping tests at 9-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up. | 9-month follow-up |
참여 도우미
적격성 기준
연령대
어린이, 성인
참여 가능한 성별
여성
- 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.
- 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);
Fujian Maternity and Child Health Hospital연구 책임자
Binhua Dong, 책임연구자, Principal Investigator, Fujian Maternity and Child Health Hospital
연구 대표 연락처
연락처: Binhua Dong, +86-591-87558732, [email protected]
연락처: Pengming Sun, +86-591-87558732, [email protected]
20 1개국에 임상시험 장소
Fujian
Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China
Binhua Dong, 연락처, +8613599071900, [email protected]
모집중
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Peifang Chen, 연락처
모집중
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Lihong Chen, 연락처
모집중
Longyan First Hospital, Longyan, Fujian, China
Jinyong Wang, 연락처
모집중
The Second Hospital of Longyan, Longyan, Fujian, China
Wenrong Huang, 연락처
모집중
Ningde Municipal Hospital of Ningde Normal University, Ningde, Fujian, 352100, China
Wenfang Jin, 연락처, +8618559336833
모집중
The First Hospital of Putian City, Putian, Fujian, 351100, China
Xianqian Chen, 연락처, +8618559336833
모집중
The Affiliated Hospital of Putian University, Putian, Fujian, China
Lijun Li, 연락처
모집중
Sanming Second Hospital, Sanming, Fujian, China
Yisheng Lin, 연락처
모집중
Zhangzhou affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, 363000, China
Feifeng Shi, M.D, 연락처, +8613960086066
모집중
Gansu
Gansu Provincial Maternal and Child Health Care Hospital, Lanzhou, Gansu, China
Xunyuan Tuo, 연락처
모집중
Guangdong
Shenzhen Maternity and Child HealthCare Hospital, Shenzhen, Guangdong, China
Zheng Zheng, 연락처
모집중
Guizhou
Guiyang maternal and child health care hospital, Guiyang, Guizhou, China
Juntao Wang, 연락처
모집중
Hubei
Hubei Maternal and Child Health Care Hospital, Wuhan, Hubei, China
Hongning Cai, 연락처
모집중
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Yan Li, 연락처
모집중
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Wei Zhang, 연락처
모집중
Jiangxi
Jiangxi maternal and Child Health Hospital, Nanchang, Jiangxi, China
Ling Li, 연락처
모집중
Shanghai Municipality
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai Municipality, China
Xiaowen Pu, 연락처
모집중
Shanxi
Northwest Women's and Children's Hospital, Xi’an, Shanxi, China
Hongwei Tan, 연락처
모집중
Zhejiang
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China
Yutao Guan, 연락처
모집중