HPV InfectionNCT05282745
A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL
An observational study of HPV Infection and HSIL, High-Grade Squamous Intraepithelial Lesions, run by Fujian Maternity and Child Health Hospital at 10 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HSIL, High-Grade Squamous Intraepithelial Lesions, Viral Load
- What is being tested?
- Follow-up
- How many people
- 4,000 participants
- Where
- 10 sitesChina
- Study dates
- 15 Dec 2021to 31 Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese women aged 20 and over with high-grade squamous intraepithelial lesion in results of cervical histopathology.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Binhua Dong, +86-591-87558732, dbh18-jy@126.com
- Recruiting
Longyan First Hospital
Longyan
Jinyong Wang
- Recruiting
Mindong Hospital of Ningde City
Ningde, Fujian, 352000
Fang Xie, M.D
- Recruiting
Ningde Municipal Hospital of Ningde Normal University
Ningde, Fujian, 352100
Wenfang Jin
- Recruiting
The First Hospital of Putian City
Putian, Fujian, 351100
Xianqian Chen
- Recruiting
Quanzhou First Hospital Afflicated to Fujian Medical University
Quanzhou, Fujian, 362000
Yuchun' Lv, M.D
- Recruiting
Shenzhen Maternity and child Healthcare Hospital
Shenzhen
Zheng Zheng
- Recruiting
Maternity and child Hospital of Hubei Province
Wuhan
Hongning Cai
- Recruiting
Xiamen Maternity and Child Health Hospital
Xiamen
Qing Li
- Recruiting
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363000
Feifeng Shi, M.D
About this study
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.
Read the 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.
- Being tested
- Follow-up
- Medical subject headings
- Papillomavirus Infections, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical histopathology testing at baseline
Cervical histopathology was performed at baseline for all participants.
Measured: Baseline
Cervical histopathology testing at 6-month follow-up
Cervical histopathology was performed at 6-month follow-up for cervical HPV infection or cytology abnormalities women.
Measured: 6-month follow-up
Cervical histopathology testing at 12-month follow-up
Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.
Measured: 12-month follow-up
Cervical histopathology testing at 24-month follow-up
Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.
Measured: 24-month follow-up
Human Papillomavirus (HPV) viral load test at baseline
Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.
Measured: Baseline
Human Papillomavirus (HPV) viral load test at 6-month follow-up
All participants were tested for HPV viral load at the time of 6-month follow-up.
Measured: 6-month follow-up
Human Papillomavirus (HPV) viral load test at 12-month follow-up
All participants were tested for HPV viral load at the time of 12-month follow-up.
Measured: 12-month follow-up
Human Papillomavirus (HPV) viral load test at 24-month follow-up
All participants were tested for HPV viral load at the time of 24-month follow-up.
Measured: 24-month follow-up
Cervical cytology testing at baseline
All participants were tested for cervical cytology at the time of baseline.
Measured: Baseline
Cervical cytology testing at 6-month follow-up
All participants were tested for Cervical cytology testing at the time of 6-month follow-up.
Measured: 6-month follow-up
Cervical cytology testing at 12-month follow-up
All participants were tested for Cervical cytology testing at the time of 12-month follow-up.
Measured: 12-month follow-up
Cervical cytology testing at 24-month follow-up
All participants were tested for Cervical cytology testing at the time of 24-month follow-up.
Measured: 24-month follow-up
16SrRNA sequencing of the vaginal secretions at baseline
All participants underwent vaginal secretion sequencing at baseline.
Measured: Baseline
16SrRNA sequencing the vaginal secretions at 6-month follow-up
All participants underwent vaginal secretion sequencing at the time of 6-month follow-up.
Measured: 6-month follow-up
16SrRNA sequencing of the vaginal secretions at 12-month follow-up
All participants underwent vaginal secretion sequencing at the time of 12-month follow-up.
Measured: 12-month follow-up
16SrRNA sequencing of the vaginal secretions at 24-month follow-up
All participants underwent vaginal secretion sequencing at the time of 24-month follow-up.
Measured: 24-month follow-up
Secondary outcomes (4)
Human Papillomavirus (HPV) genotyping tests at baseline
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
Measured: Baseline
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 6-month follow-up.
Measured: 6-month follow-up
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 12-month follow-up.
Measured: 12-month follow-up
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 24-month follow-up.
Measured: 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Dec 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binhua Dong, Fujian Maternity and Child Health Hospital
- Investigators
- Pengming Sun, PhD, Study chair, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282745
- Sponsor's protocol ID
- PVLHCF
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of Women With HSIL in Cervix
- ClinicalTrials.gov ID
- NCT05282745
- Acronym / sponsor ID
- PVLHCF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with high-grade squamous intraepithelial lesion (HSIL) in cervix | – | Other: Follow-upIn 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese women aged 20 and over with high-grade squamous intraepithelial lesion in results of cervical histopathology.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-upParticipants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests. | Other | Women with high-grade squamous intraepithelial lesion (HSIL) in cervix |
Primary outcome
Cervical histopathology testing at baseline
Time frame: Baseline
Cervical histopathology was performed at baseline for all participants.
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.
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.
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.
Human Papillomavirus (HPV) viral load test at baseline
Time frame: Baseline
Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.
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.
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.
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.
Cervical cytology testing at baseline
Time frame: Baseline
All participants were tested for cervical cytology at the time of 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.
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.
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.
16SrRNA sequencing of the vaginal secretions at baseline
Time frame: Baseline
All participants underwent vaginal secretion sequencing at baseline.
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.
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.
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.
4 secondary outcomes
Human Papillomavirus (HPV) genotyping tests at baseline
Time frame: Baseline
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
Time frame: 6-month follow-up
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
Time frame: 12-month follow-up
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
Time frame: 24-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pengming Sun, PhD study chair
Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and HSIL, High-Grade Squamous Intraepithelial Lesions, run by Fujian Maternity and Child Health Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binhua Dong (+86-591-87558732, dbh18-jy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical histopathology testing at baseline (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.