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

• Sponsor: Fujian Maternity and Child Health Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05283239
• Collaborator: (none)
• Enrollment: 2,000
• Locations: 11
• Anticipated Duration (Months): 36
• Patients Per Site: 181.8
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
HPV Infection; LSIL, Low-Grade Squamous Intraepithelial Lesions; HSIL, High-Grade Squamous Intraepithelial Lesions; Virus Integration	Other: Follow up

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Nov 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Women with persistent HR-HPV infection In 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.	Other: Follow up; 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.

Outcome Measures

Primary Outcome Measures

1. Cervical histopathology testing at baseline [Baseline]

   Cervical histopathology was performed at baseline for all participants.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11. Cervical cytology testing at baseline [Baseline]

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

12. Cervical cytology testing at 6-month follow-up [6-month follow-up]

    All participants were tested for Cervical cytology testing at the time of 6-month follow-up.

13. Cervical cytology testing at 12-month follow-up [12-month follow-up]

    All participants were tested for Cervical cytology testing at the time of 12-month follow-up.

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

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

15. Cervical cytology testing at 24-month follow-up [24-month follow-up]

    All participants were tested for Cervical cytology testing at the time of 24-month follow-up.

16. Human Papillomavirus (HPV) genotyping tests at baseline [Baseline]

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures

1. 16SrRNA sequencing of the vaginal secretions at baseline [Baseline]

   All participants underwent vaginal secretion sequencing at baseline.

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

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

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

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

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

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

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

   All participants underwent vaginal secretion sequencing at 24-month follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian	China	350001
2	Mindong Hospital of Ningde City	Ningde	Fujian	China	352000
3	Ningde Municipal Hospital of Ningde Normal University	Ningde	Fujian	China	352100
4	The First Hospital of Putian City	Putian	Fujian	China	351100
5	Quanzhou First Hospital Afflicated to Fujian Medical University	Quanzhou	Fujian	China	362000
6	Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University	Xiamen	Fujian	China	361000
7	Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian	China	363000
8	Longyan First Hospital	Longyan		China
9	Nanping Second Hospital	Nanjing		China
10	Sanming Second Hospital	Sanming		China
11	Shenzhen Maternity and child Healthcare Hospital	Shenzhen		China

Sponsors and Collaborators

• Fujian Maternity and Child Health Hospital

Investigators

• Study Chair: Binhua Dong, MD, Fujian Maternity and Child Health Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Binhua Dong, Principal Investigator, Fujian Maternity and Child Health Hospital
• ClinicalTrials.gov Identifier: NCT05283239
• Other Study ID Numbers: HIHP2201
• First Posted: Mar 16, 2022
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Squamous Intraepithelial Lesions of the Cervix

Study Results

No Results Posted as of Mar 16, 2022