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Cervical Intraepithelial NeoplasiaNCT05282095

Effect of HPV Integration on Prognosis of Young Women With CIN2 in China

An observational study of Cervical Intraepithelial Neoplasia and HPV Infection, run by Fujian Maternity and Child Health Hospital at 20 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 The sponsor has not verified this record for over two years, so it may be out of date.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, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. Read more about this study

Who is it for?
Ages Up to 45 years, women only
What is being tested?
Follow up
How many people
300 participants
Where
20 sitesChina
Study dates
1 Jun 2022to 31 May 2026
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 Up to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Study population: ≤45 years old Chinese women with cervical histopathology for CIN2.

Who may be able to join

  • Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;
  • Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;
  • The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;
  • Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;
  • Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.

Who cannot join

  • Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;
  • Pregnant or lactating;
  • History of malignant reproductive tract tumors;
  • History of hysterectomy, cervical surgery, or pelvic radiation therapy;
  • Physical therapy to the cervix within 24 months prior to enrollment;
  • The subject has a severe immune system disease that is active;
Show all 11Show fewer
  • Long-term use of contraceptives within 12 months prior to enrollment;
  • Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);
  • Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);
  • Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);
  • Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);

Trial locations and contacts

20 sites in 1 country.

Binhua Dong contact

+86-591-87558732

dbh18-jy@126.com

Pengming Sun contact

+86-591-87558732

sunfemy@hotmail.com

20 sites in 1 country

China20 sites, 20 recruiting

  • Fujian Maternity and Child Health Hospital

    Fuzhou, Fujian, 350001

    Binhua Dong, +8613599071900, dbh18-jy@126.com

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Peifang Chen

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Lihong Chen

    Recruiting

  • Guiyang maternal and child health care hospital

    Guiyang, Guizhou

    Juntao Wang

    Recruiting

  • Gansu Provincial Maternal and Child Health Care Hospital

    Lanzhou, Gansu

    Xunyuan Tuo

    Recruiting

  • Longyan First Hospital

    Longyan, Fujian

    Jinyong Wang

    Recruiting

  • The Second Hospital of Longyan

    Longyan, Fujian

    Wenrong Huang

    Recruiting

  • Jiangxi maternal and Child Health Hospital

    Nanchang, Jiangxi

    Ling Li

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Yutao Guan

    Recruiting

  • Ningde Municipal Hospital of Ningde Normal University

    Ningde, Fujian, 352100

    Wenfang Jin, +8618559336833

    Recruiting

  • The First Hospital of Putian City

    Putian, Fujian, 351100

    Xianqian Chen, +8618559336833

    Recruiting

  • The Affiliated Hospital of Putian University

    Putian, Fujian

    Lijun Li

    Recruiting

  • Sanming Second Hospital

    Sanming, Fujian

    Yisheng Lin

    Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai Municipality

    Xiaowen Pu

    Recruiting

  • Shenzhen Maternity and Child HealthCare Hospital

    Shenzhen, Guangdong

    Zheng Zheng

    Recruiting

  • Hubei Maternal and Child Health Care Hospital

    Wuhan, Hubei

    Hongning Cai

    Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei

    Yan Li

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Wei Zhang

    Recruiting

  • Northwest Women's and Children's Hospital

    Xi’an, Shanxi

    Hongwei Tan

    Recruiting

  • Zhangzhou affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000

    Feifeng Shi, M.D, +8613960086066

    Recruiting

Other trials in China

About this study

Official title: Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China

Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science \& Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.

Read the detailed description

This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.

Being tested
Follow up
Medical subject headings
Uterine Cervical Dysplasia, 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 baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.

Study groups in NCT05282095
Study groupRoleWhat they receive
Women aged from 18-45 with histopathologically confirmed CIN2In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month.
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 all participants.

    Measured: 6-month follow-up

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

    Cervical histopathology was performed at 12-month follow-up for all participants.

    Measured: 12-month follow-up

  4. Human Papillomavirus (HPV) viral integration test at baseline

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

    Measured: Baseline

  5. Human Papillomavirus (HPV) viral integration test at 6-month follow-up

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

    Measured: 6-month follow-up

  6. Human Papillomavirus (HPV) viral integration test at 12-month follow-up

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

    Measured: 12-month follow-up

  7. Cervical cytology testing at baseline

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

    Measured: Baseline

  8. Cervical cytology testing at 3-month follow-up

    All participants were tested for cervical cytology at 3-month follow-up.

    Measured: 3-month follow-up

  9. Cervical cytology testing at 6-month follow-up

    All participants were tested for cervical cytology at 6-month follow-up

    Measured: 6-month follow-up

  10. Cervical cytology testing at 9-month follow-up

    All participants were tested for cervical cytology at 9-month follow-up

    Measured: 9-month follow-up

  11. Cervical cytology testing at 12-month follow-up

    All participants were tested for cervical cytology at 12-month follow-up

    Measured: 12-month follow-up

  12. 16SrRNA sequencing of the vaginal secretions at baseline

    All participants underwent vaginal secretion sequencing at baseline.

    Measured: Baseline

  13. 16SrRNA sequencing of the vaginal secretions at 3-month follow-up

    All participants underwent vaginal secretion sequencing at 3-month follow-up.

    Measured: 3-month follow-up

  14. 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

  15. 16SrRNA sequencing of the vaginal secretions at 9-month follow-up

    All participants underwent vaginal secretion sequencing at 9-month follow-up

    Measured: 9-month follow-up

  16. 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

  17. Human Papillomavirus (HPV) genotyping tests at baseline

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

    Measured: Baseline

  18. Human Papillomavirus (HPV) genotyping tests at 3-month follow-up

    All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up.

    Measured: 3-month follow-up

  19. Human Papillomavirus (HPV) genotyping tests at 9-month follow-up

    All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up.

    Measured: 9-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 Jun 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 May 2026 (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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282095
Sponsor's protocol ID
HPVZHCIN22021
Status last verified
Sep 2024
First submitted
7 Mar 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Zhang Y, Hu T, Pu X, Dong B, Tuo X, Zou H, Zhang W, Lyu Q, Huang W, Xue H, Xu S, Osafo KS, Ren Y, Lin W, Su J, Huang X, Sun P. Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study. BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863.

    PubMed 40295124

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Intraepithelial Neoplasia and HPV Infection, run by Fujian Maternity and Child Health Hospital at 20 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 5 inclusion and 11 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 19 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 NCT05282095, which also lists 1 linked publication.

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 19 Sep 2024.

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