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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • 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:
      • Ningde, Fujian, China, 352000
        • Recruiting
        • MinDong Hospital of Ningde City
        • Contact:
          • Fang Xie, M.D
      • Ningde, Fujian, China, 352100
        • Recruiting
        • Ningde Municipal Hospital of Ningde Normal University
        • Contact:
          • Wenfang Jin
      • Putian, Fujian, China, 351100
        • Recruiting
        • The First Hospital of Putian City
        • Contact:
          • Xianqian Chen
      • Quanzhou, Fujian, China, 362000
        • Recruiting
        • Quanzhou First Hospital Afflicated to Fujian Medical University
        • Contact:
          • Yuchun' Lv, M.D
      • Zhangzhou, Fujian, China, 363000
        • Recruiting
        • Zhangzhou Affiliated hospital of Fujian Medical University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Follow-up
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Maternity and Child Health Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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