HPV InfectionNCT05745597
Prognostic Study of HPV Virus Integration in Women With HSIL
An observational study of HPV Infection and Virus Integration, run by Fujian Maternity and Child Health Hospital at 13 sites in China.
Trial summary
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HPV Infection, Virus Integration, HSIL, High Grade Squamous Intraepithelial Lesions
- What is being tested?
- Follow up
- How many people
- 1,000 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jan 2023to 31 Oct 2025
- 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: Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive carcinoma
Who may be able to join
- Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer;
- No surgical treatment or conization only;
- Obtain informed consent.
Who cannot join
- During pregnancy or lactation;
- Patients with a history of genital tract cancer;
- Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
- Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
- Use of antibiotics or vaginal microecological improvement products in the past 1 month.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 6 recruiting
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Binhua Dong, +8613599071900, dbh18-jy@126.com
- Active, not recruiting
Longyan First Hospital
Longyan, Fujian
- Active, not recruiting
Longyan People's Hospital
Longyan, Fujian
- Recruiting
Nanping Second Hospital
Nanping, Fujian
Caiping Deng, 086-599-5621267
- Recruiting
Mindong Hospital of Ningde City
Ningde, Fujian
Fang Xie, M.D
- Active, not recruiting
Ningde City Hospital
Ningde, Fujian
- Active, not recruiting
Affiliated Hospital of Putian University
Putian, Fujian
- Recruiting
Putian First Hospital
Putian, Fujian
Xianqian Chen
- Recruiting
Sanming Second Hospital
Sanming, Fujian
Yisheng Lin, 086-13507576151
- Recruiting
Shenzhen Maternity and child Healthcare Hospital
Shenzhen, Guangdong
Zheng Zheng
- Active, not recruiting
Shijiazhuang Obstetrics and Gynecology Hospital
Shijiazhuang, Hebei
- Active, not recruiting
Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
- Active, not recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei
About this study
Official title: Prognostic Study of Different HPV Virus Integration in Women With HSIL
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.
Read the detailed description
A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.
- 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
Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology | In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24. Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 at 6-month follow-up for all participants.
Measured: 6-month follow-up
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
Cervical cytology testing at 24-month follow-up
Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 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 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
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
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
Human Papillomavirus (HPV) viral integration test at baseline
Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
Measured: Baseline
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
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
Human Papillomavirus (HPV) viral integration test at 24-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.
Measured: 24-month follow-up
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 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 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 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 posted27 Feb 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengming Sun, Study chair, Fujian Maternal and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745597
- Sponsor's protocol ID
- HINH2301
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Different HPV Virus Integration in Women With HSIL
- ClinicalTrials.gov ID
- NCT05745597
- Acronym / sponsor ID
- HINH2301
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 27 Feb 2023 (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) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.
Detailed description
A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology | – | Other: Follow upIn this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive carcinoma
Key inclusion criteria (3 listed)
- Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer;
- No surgical treatment or conization only;
- Obtain informed consent.
Key exclusion criteria (5 listed)
- During pregnancy or lactation;
- Patients with a history of genital tract cancer;
- Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
- Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
- Use of antibiotics or vaginal microecological improvement products in the past 1 month.
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 upFour samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment. | Other | HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology |
Primary outcome
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 at 6-month follow-up for all participants.
Cervical cytology testing at 12-month follow-up
Time frame: 12-month follow-up
All participants were tested for cervical cytology at 12-month follow-up
Cervical cytology testing at 24-month follow-up
Time frame: 24-month follow-up
Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 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 of the vaginal secretions at 6-month follow-up
Time frame: 6-month follow-up
All participants underwent vaginal secretion sequencing at 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 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 24-month follow-up
Human Papillomavirus (HPV) viral integration test at baseline
Time frame: Baseline
Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
Human Papillomavirus (HPV) viral integration test at 6-month follow-up
Time frame: 6-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.
Human Papillomavirus (HPV) viral integration test at 12-month follow-up
Time frame: 12-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.
Human Papillomavirus (HPV) viral integration test at 24-month follow-up
Time frame: 24-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.
Human Papillomavirus (HPV) genotyping tests at baseline
Time frame: Baseline
All participants underwent Human Papillomavirus (HPV) genotyping tests at 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 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 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 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 27 Feb 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 study chair
Fujian Maternal and Child Health Hospital
13 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 Virus Integration, run by Fujian Maternity and Child Health Hospital at 13 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 3 inclusion and 5 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 cytology 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 27 Feb 2023.