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HPV InfectionNCT05283239

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

An observational study of HPV Infection and LSIL, Low-Grade Squamous Intraepithelial Lesions, run by Fujian Maternity and Child Health Hospital at 11 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Follow up
How many people
1,000 participants
Where
11 sitesChina
Study dates
1 Jan 2022to 31 Dec 2024
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Chinese women with persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +.

Who may be able to join

  • Non pregnant people with sexual history；
  • Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
  • No history of previous surgery at the cervical site.
  • 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

11 sites in 1 country.

Binhua Dong contact

+86-591-87558732

dbh18-jy@126.com

Pengming Sun, Study Chair contact

+86-591-87558732

sunfemy@hotmail.com

11 sites in 1 country

China11 sites, 11 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

  • Nanping Second Hospital

    Nanjing

    Caiping Deng

    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

  • Sanming Second Hospital

    Sanming

    Yisheng Lin

    Recruiting

  • Shenzhen Maternity and child Healthcare Hospital

    Shenzhen

    Zheng Zheng

    Recruiting

  • Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

    Xiamen, Fujian, 361000

    Qing Li, M.D

    Recruiting

  • Zhangzhou affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000

    Feifeng Shi, M.D

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

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.

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 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.

Study groups in NCT05283239
Study groupRoleWhat they receive
Women with persistent HR-HPV infectionIn 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.
Receives: Other: Follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical histopathology testing at baseline

    Cervical histopathology was performed at baseline for all participants.

    Measured: Baseline

  2. Cervical histopathology testing at 6-month follow-up

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

    Measured: 6-month follow-up

  3. Cervical histopathology testing at 12-month follow-up

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

    Measured: 12-month follow-up

  4. Cervical histopathology testing at 18-month follow-up

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

    Measured: 18-month follow-up

  5. Cervical histopathology testing at 24-month follow-up

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

    Measured: 24-month follow-up

  6. Human Papillomavirus (HPV) virus integration test at baseline

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

    Measured: Baseline

  7. Human Papillomavirus (HPV) virus integration test at 6-month follow-up

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

    Measured: 6-month follow-up

  8. Human Papillomavirus (HPV) virus integration test at 12-month follow-up

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

    Measured: 12-month follow-up

  9. Human Papillomavirus (HPV) virus integration test at 18-month follow-up

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

    Measured: 18-month follow-up

  10. Human Papillomavirus (HPV) virus integration test at 24-month follow-up

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

    Measured: 24-month follow-up

  11. Cervical cytology testing at baseline

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

    Measured: Baseline

  12. 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

  13. 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

  14. Cervical cytology testing at 18-month follow-up

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

    Measured: 18-month follow-up

  15. 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

  16. Human Papillomavirus (HPV) genotyping tests at baseline

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

    Measured: Baseline

  17. Human Papillomavirus (HPV) genotyping tests at 6-month follow-up

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

    Measured: 6-month follow-up

  18. Human Papillomavirus (HPV) genotyping tests at 12-month follow-up

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

    Measured: 12-month follow-up

  19. Human Papillomavirus (HPV) genotyping tests at 18-month follow-up

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

    Measured: 18-month follow-up

  20. Human Papillomavirus (HPV) genotyping tests at 24-month follow-up

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

    Measured: 24-month follow-up

Secondary outcomes (5)

  1. 16SrRNA sequencing of the vaginal secretions at baseline

    All participants underwent vaginal secretion sequencing at baseline.

    Measured: Baseline

  2. 16SrRNA sequencing of the vaginal secretions at 6-month follow-up

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

    Measured: 6-month follow-up

  3. 16SrRNA sequencing of the vaginal secretions at 12-month follow-up

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

    Measured: 12-month follow-up

  4. 16SrRNA sequencing of the vaginal secretions at 18-month follow-up

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

    Measured: 18-month follow-up

  5. 16SrRNA sequencing of the vaginal secretions at 24-month follow-up

    All participants underwent vaginal secretion sequencing at 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.

  1. First posted16 Mar 2022
  2. Study start1 Jan 2022
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283239
Sponsor's protocol ID
HIHP2201
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

Questions about this trial

What is this clinical trial studying?

An observational study of HPV Infection and LSIL, Low-Grade Squamous Intraepithelial Lesions, run by Fujian Maternity and Child Health Hospital at 11 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 11 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 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05283239.

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.

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