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O estudo clínico NCT05282095 para Neoplasia Intraepitelial Cervical, Infecção por HPV, Integração viral, HSIL, lesões intraepiteliais escamosas de alto grau está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Effect of HPV Integration on Prognosis of Young Women With CIN2 in China 300
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05282095 é um estudo observacional para Neoplasia Intraepitelial Cervical, Infecção por HPV, Integração viral, HSIL, lesões intraepiteliais escamosas de alto grau. Seu status atual é: em recrutamento. O estudo começou em 1 de junho de 2022 e pretende incluir 300 participantes. Coordenado por Fujian Maternity and Child Health Hospital e deve ser concluído em 31 de maio de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de setembro de 2024.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
Condições médicas
Neoplasia Intraepitelial CervicalInfecção por HPVIntegração viralHSIL, lesões intraepiteliais escamosas de alto grauPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- HPVZHCIN22021
Número NCT
Data de início (real)
2022-06-01
Última atualização postada
2024-09-19
Data de conclusão (estimada)
2026-05-31
Inscrição (estimada)
300
Tipo de estudo
Observacional
Status
Em recrutamento
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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. | Acompanhamento 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. |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Sexos elegíveis
Feminino
- 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 HospitalResponsável pelo estudo
Binhua Dong, Investigador principal, Principal Investigator, Fujian Maternity and Child Health Hospital
Contato central do estudo
Contato: Binhua Dong, +86-591-87558732, [email protected]
Contato: Pengming Sun, +86-591-87558732, [email protected]
20 Locais do estudo em 1 países
Fujian
Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China
Binhua Dong, Contato, +8613599071900, [email protected]
Em recrutamento
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Peifang Chen, Contato
Em recrutamento
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Lihong Chen, Contato
Em recrutamento
Longyan First Hospital, Longyan, Fujian, China
Jinyong Wang, Contato
Em recrutamento
The Second Hospital of Longyan, Longyan, Fujian, China
Wenrong Huang, Contato
Em recrutamento
Ningde Municipal Hospital of Ningde Normal University, Ningde, Fujian, 352100, China
Wenfang Jin, Contato, +8618559336833
Em recrutamento
The First Hospital of Putian City, Putian, Fujian, 351100, China
Xianqian Chen, Contato, +8618559336833
Em recrutamento
The Affiliated Hospital of Putian University, Putian, Fujian, China
Lijun Li, Contato
Em recrutamento
Sanming Second Hospital, Sanming, Fujian, China
Yisheng Lin, Contato
Em recrutamento
Zhangzhou affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, 363000, China
Feifeng Shi, M.D, Contato, +8613960086066
Em recrutamento
Gansu
Gansu Provincial Maternal and Child Health Care Hospital, Lanzhou, Gansu, China
Xunyuan Tuo, Contato
Em recrutamento
Guangdong
Shenzhen Maternity and Child HealthCare Hospital, Shenzhen, Guangdong, China
Zheng Zheng, Contato
Em recrutamento
Guizhou
Guiyang maternal and child health care hospital, Guiyang, Guizhou, China
Juntao Wang, Contato
Em recrutamento
Hubei
Hubei Maternal and Child Health Care Hospital, Wuhan, Hubei, China
Hongning Cai, Contato
Em recrutamento
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Yan Li, Contato
Em recrutamento
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Wei Zhang, Contato
Em recrutamento
Jiangxi
Jiangxi maternal and Child Health Hospital, Nanchang, Jiangxi, China
Ling Li, Contato
Em recrutamento
Shanghai Municipality
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai Municipality, China
Xiaowen Pu, Contato
Em recrutamento
Shanxi
Northwest Women's and Children's Hospital, Xi’an, Shanxi, China
Hongwei Tan, Contato
Em recrutamento
Zhejiang
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China
Yutao Guan, Contato
Em recrutamento