- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05282745
A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL
November 15, 2023 updated by: Binhua Dong, Fujian Maternity and Child Health Hospital
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Binhua Dong
- Phone Number: +86-591-87558732
- Email: dbh18-jy@126.com
Study Locations
-
-
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Longyan, China
- Recruiting
- Longyan First Hospital
-
Contact:
- Jinyong Wang
-
Shenzhen, China
- Recruiting
- Shenzhen Maternity and Child Healthcare Hospital
-
Contact:
- Zheng Zheng
-
Wuhan, China
- Recruiting
- Maternity and child Hospital of Hubei Province
-
Contact:
- Hongning Cai
-
Xiamen, China
- Recruiting
- Xiamen Maternity and Child Health Hospital
-
Contact:
- Qing Li
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Recruiting
- Fujian Maternity and Child Health Hospital
-
Contact:
- Binhua Dong
- Phone Number: +86-591-87558732
- Email: dbh18-jy@126.com
-
Ningde, Fujian, China, 352000
- Recruiting
- MinDong Hospital of Ningde City
-
Contact:
- Fang Xie, M.D
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Ningde, Fujian, China, 352100
- Recruiting
- Ningde Municipal Hospital of Ningde Normal University
-
Contact:
- Wenfang Jin
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Putian, Fujian, China, 351100
- Recruiting
- The First Hospital of Putian City
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Contact:
- Xianqian Chen
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Quanzhou, Fujian, China, 362000
- Recruiting
- Quanzhou First Hospital Afflicated to Fujian Medical University
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Contact:
- Yuchun' Lv, M.D
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Zhangzhou, Fujian, China, 363000
- Recruiting
- Zhangzhou Affiliated Hospital of Fujian Medical University
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Contact:
- Feifeng Shi, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Chinese women aged 20 and over with high-grade squamous intraepithelial lesion in results of cervical histopathology.
Description
Inclusion Criteria:
- Women aged 20 and over.
- The result of cervical histopathology in the last 3 months was high-grade squamous intraepithelial lesion (HSIL).
- Non pregnant people with sexual history.
- Asexual life, no vaginal medication or flushing before 72 hours of sampling.
Exclusion Criteria:
- Within 8 weeks after pregnancy or postpartum.
- Patients with history of genital tract tumor.
- History of HPV vaccination.
- Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
- In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
- Use antibiotics or vaginal microecological improvement products in recent 1 month.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women with high-grade squamous intraepithelial lesion (HSIL) in cervix
In the enrollment, women whose cervical histopathological results have been diagnosed as high-grade squamous intraepithelial lesion (HSIL) for the last 3 months with abnormal results will be included in this study.
All participants will be followed up three times, at 6 months,12 months and 24 months.
|
Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical histopathology testing at baseline
Time Frame: Baseline
|
Cervical histopathology was performed at baseline for all participants.
|
Baseline
|
Cervical cytology testing at baseline
Time Frame: Baseline
|
All participants were tested for cervical cytology at the time of baseline.
|
Baseline
|
Cervical cytology testing at 6-month follow-up
Time Frame: 6-month follow-up
|
All participants were tested for Cervical cytology testing at the time of 6-month follow-up.
|
6-month follow-up
|
Cervical cytology testing at 12-month follow-up
Time Frame: 12-month follow-up
|
All participants were tested for Cervical cytology testing at the time of 12-month follow-up.
|
12-month follow-up
|
Cervical cytology testing at 24-month follow-up
Time Frame: 24-month follow-up
|
All participants were tested for Cervical cytology testing at the time of 24-month follow-up.
|
24-month follow-up
|
16SrRNA sequencing of the vaginal secretions at baseline
Time Frame: Baseline
|
All participants underwent vaginal secretion sequencing at baseline.
|
Baseline
|
Cervical histopathology testing at 6-month follow-up
Time Frame: 6-month follow-up
|
Cervical histopathology was performed at 6-month follow-up for cervical HPV infection or cytology abnormalities women.
|
6-month follow-up
|
Cervical histopathology testing at 12-month follow-up
Time Frame: 12-month follow-up
|
Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.
|
12-month follow-up
|
Cervical histopathology testing at 24-month follow-up
Time Frame: 24-month follow-up
|
Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.
|
24-month follow-up
|
Human Papillomavirus (HPV) viral load test at baseline
Time Frame: Baseline
|
Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.
|
Baseline
|
Human Papillomavirus (HPV) viral load test at 6-month follow-up
Time Frame: 6-month follow-up
|
All participants were tested for HPV viral load at the time of 6-month follow-up.
|
6-month follow-up
|
Human Papillomavirus (HPV) viral load test at 12-month follow-up
Time Frame: 12-month follow-up
|
All participants were tested for HPV viral load at the time of 12-month follow-up.
|
12-month follow-up
|
Human Papillomavirus (HPV) viral load test at 24-month follow-up
Time Frame: 24-month follow-up
|
All participants were tested for HPV viral load at the time of 24-month follow-up.
|
24-month follow-up
|
16SrRNA sequencing the vaginal secretions at 6-month follow-up
Time Frame: 6-month follow-up
|
All participants underwent vaginal secretion sequencing at the time of 6-month follow-up.
|
6-month follow-up
|
16SrRNA sequencing of the vaginal secretions at 12-month follow-up
Time Frame: 12-month follow-up
|
All participants underwent vaginal secretion sequencing at the time of 12-month follow-up.
|
12-month follow-up
|
16SrRNA sequencing of the vaginal secretions at 24-month follow-up
Time Frame: 24-month follow-up
|
All participants underwent vaginal secretion sequencing at the time of 24-month follow-up.
|
24-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Human Papillomavirus (HPV) genotyping tests at baseline
Time Frame: Baseline
|
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
|
Baseline
|
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
Time Frame: 6-month follow-up
|
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 6-month follow-up.
|
6-month follow-up
|
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
Time Frame: 12-month follow-up
|
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 12-month follow-up.
|
12-month follow-up
|
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
Time Frame: 24-month follow-up
|
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 24-month follow-up.
|
24-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Pengming Sun, PhD, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2021
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
February 17, 2022
First Submitted That Met QC Criteria
March 7, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVLHCF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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