Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Rare Diseases

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Squamous Intraepithelial Lesions of the Cervix

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.

Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.

Follow up

Binhua Dong

Pengming Sun, Study Chair

Fang Xie, M.D

Wenfang Jin

Xianqian Chen

Yuchun' Lv, M.D

Qing Li, M.D

Feifeng Shi, M.D

Jinyong Wang

Caiping Deng

Yisheng Lin

Zheng Zheng

Binhua Dong, MD

Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.

This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.

Samples from cervix and vagina containing related cells, tissues and secretions.

Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection

Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China

Cervical histopathology was performed at baseline for all participants.

Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women

Cervical histopathology was performed at 12-month follow-up for cervical HR-HPV infection or cytology abnormalities women

Cervical histopathology was performed at 18-month follow-up for cervical HR-HPV infection or cytology abnormalities women

Cervical histopathology was performed at 24-month follow-up for cervical HR-HPV infection or cytology abnormalities women

Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.

Human Papillomavirus (HPV) virus integration test was performed at 6-month follow-up for all participants.

Human Papillomavirus (HPV) virus integration test was performed at 12-month follow-up for all participants.

Human Papillomavirus (HPV) virus integration test was performed at 18-month follow-up for all participants.

Human Papillomavirus (HPV) virus integration test was performed at 24-month follow-up for all participants.

All participants were tested for cervical cytology at the time of baseline.

All participants were tested for Cervical cytology testing at the time of 6-month follow-up.

All participants were tested for Cervical cytology testing at the time of 12-month follow-up.

All participants were tested for Cervical cytology testing at the time of 18-month follow-up.

All participants were tested for Cervical cytology testing at the time of 24-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.

All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.

All participants underwent vaginal secretion sequencing at baseline.

All participants underwent vaginal secretion sequencing at 6-month follow-up.

All participants underwent vaginal secretion sequencing at 12-month follow-up.

All participants underwent vaginal secretion sequencing at 18-month follow-up.

All participants underwent vaginal secretion sequencing at 24-month follow-up.

Fujian Maternity and Child Health Hospital

Principal Investigator

In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24.

Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.

Pengming Sun

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.

Samples from the cervix and vagina containing relevant cells, tissues and secretions, as well as peripheral blood samples.

Prognostic Study of HPV Virus Integration in Women With HSIL

Prognostic Study of Different HPV Virus Integration in Women With HSIL

All participants were tested for cervical cytology at 6-month follow-up for all participants.

All participants were tested for cervical cytology at 12-month follow-up

Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 24-month follow-up

All participants underwent vaginal secretion sequencing at 6-month follow-up

All participants underwent vaginal secretion sequencing at 12-month follow-up

All participants underwent vaginal secretion sequencing at 24-month follow-up

Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.

Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection	NCT05283239	HPV Infection LSIL, Low-Grade... HSIL, High-Grad... Virus Integrati...	Follow up	-	Fujian Maternity and Child Health Hospital
Prognostic Study of HPV Virus Integration in Women With HSIL	NCT05745597	HPV Infection Virus Integrati... HSIL, High Grad...	Follow up	-	Fujian Maternity and Child Health Hospital
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection	NCT05283239	HPV Infection LSIL, Low-Grade... HSIL, High-Grad... Virus Integrati...	Follow up	-	Fujian Maternity and Child Health Hospital

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