HPV Infection Clinical Trial
Official title:
A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of Women With HSIL in Cervix
Human papillomavirus (HPV) infection has become one of the most important health problems faced by women all over the world. A large number of studies have shown that women's cervical, vaginal and perianal precancerous lesions, related cancers, condyloma acuminatum and other sexually transmitted diseases (STD) are closely related to HPV infection. Among them, the persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types (such as type-16, -18, -39 and -52) on different levels of cervical lesions, and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions. In addition, other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 / CIN3 high-grade cervical lesions, and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion (LSIL) and cervical high-grade squamous intraepithelial lesion (HSIL). The above biological changes such as HPV infection type, quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees. It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening.
Based on previous studies and clinical practice, this study carried out a multi center cohort study in China. In this study, ten research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University, The First Hospital of Putian City, Ningde Municipal Hospital of Ningde Normal University, Shenzhen Maternity and child Healthcare Hospital and Maternity and child Hospital of Hubei Province were included, each of which included 400 individuals, with a total of 4000 women with high-grade squamous intraepithelial lesion were enrolled. For the first time, the investigators will collect 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs from participants, then at the 6th, 12th and 24th months after the first sampling, the participants need to return to the hospital, collected 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs again in order to observe and record the development of the disease. During this process, if abnormal cervical lesions are found, the participants will be biopsied under colposcopy according to relevant guidelines. Samples from cervix would be sent for PCR-sequencing, HPV tests and Thinprep cytologic test (TCT). And samples from vaginal fornix would be sent for sequencing and bioinformatic analysis. A prospective cohort study was conducted to explore the correlation between the characteristics, progression and prognosis of female genital tract lesions and HPV infection type, load and vaginal microenvironment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04098744 -
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
|
Phase 2 | |
| Completed |
NCT04083196 -
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
|
Phase 1 | |
| Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
| Withdrawn |
NCT04430907 -
HPV Vaccine in Postpartum Women
|
||
| Recruiting |
NCT02593968 -
Yallaferon in Chinese Population
|
Phase 2 | |
| Completed |
NCT04711265 -
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
|
||
| Completed |
NCT02263378 -
A New Supplement for the Immune Response to HPV Infection
|
N/A | |
| Completed |
NCT05234112 -
Prevention and Screening Towards Elimination of Cervical Cancer
|
N/A | |
| Completed |
NCT04590521 -
HPV Vaccine Immunity in High-risk Women
|
Phase 4 | |
| Recruiting |
NCT05829629 -
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
|
Phase 1 | |
| Recruiting |
NCT06052033 -
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
|
N/A | |
| Recruiting |
NCT05051852 -
HPV Viral Load in Predicting the Prognosis of LSIL
|
||
| Completed |
NCT04155294 -
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
|
||
| Active, not recruiting |
NCT06452004 -
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
|
N/A | |
| Completed |
NCT06177236 -
Clinic or Self-Sampling for Cervical Cancer Screening
|
N/A | |
| Active, not recruiting |
NCT04794660 -
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
|
Phase 3 | |
| Recruiting |
NCT05509413 -
DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections
|
N/A | |
| Recruiting |
NCT06137950 -
Interferon Alpha Therapy for Cervical CINI and HPV Infection
|
Phase 1 | |
| Recruiting |
NCT04171505 -
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
|
||
| Active, not recruiting |
NCT05524025 -
The SPOT-HPV Study
|