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

NCT05283239 | Unknown DMC

• 1 other identifier: HIHP2201
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 11

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.

Conditions

HPV Infection; LSIL, Low-Grade Squamous Intraepithelial Lesions; HSIL, High-Grade Squamous Intraepithelial Lesions; Virus Integration

Outcome Measures

Primary Outcomes (20)

• Cervical histopathology testing at baseline

  Cervical histopathology was performed at baseline for all participants.

  Baseline

• 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

  6-month follow-up

• 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

  12-month follow-up

• 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

  18-month follow-up

• 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

  24-month follow-up

• Human Papillomavirus (HPV) virus integration test at baseline

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

  Baseline

• 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.

  6-month follow-up

• 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.

  12-month follow-up

• 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.

  18-month follow-up

• 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.

  24-month follow-up

• Cervical cytology testing at baseline

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

  Baseline

• Cervical cytology testing at 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

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

  12-month follow-up

• Cervical cytology testing at 18-month follow-up

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

  18-month follow-up

• Cervical cytology testing at 24-month follow-up

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

  24-month follow-up

• Human Papillomavirus (HPV) genotyping tests at baseline

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

  Baseline

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

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

  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.

  12-month follow-up

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

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

  18-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.

  24-month follow-up

Secondary Outcomes (5)

• 16SrRNA sequencing of the vaginal secretions at baseline

  Baseline

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

  6-month follow-up

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

  12-month follow-up

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

  18-month follow-up

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

  24-month follow-up

Study Arms (1)

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

Interventions

Follow up OTHER

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.

Women with persistent HR-HPV infection

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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 +.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (11)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Mindong Hospital of Ningde City

Ningde, Fujian, 352000, China

RECRUITING

Ningde Municipal Hospital of Ningde Normal University

Ningde, Fujian, 352100, China

RECRUITING

The First Hospital of Putian City

Putian, Fujian, 351100, China

RECRUITING

Quanzhou First Hospital Afflicated to Fujian Medical University

Quanzhou, Fujian, 362000, China

RECRUITING

Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

RECRUITING

Longyan First Hospital

Longyan, China

RECRUITING

Nanping Second Hospital

Nanjing, China

RECRUITING

Sanming Second Hospital

Sanming, China

RECRUITING

Shenzhen Maternity and child Healthcare Hospital

Shenzhen, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples from cervix and vagina containing related cells, tissues and secretions.

MeSH Terms

Conditions

Papillomavirus Infections; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Officials

• Binhua Dong, MD

  Fujian Maternity and Child Health Hospital

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

+86-591-87558732; dbh18-jy@126.com

Pengming Sun, Study Chair

CONTACT

+86-591-87558732; sunfemy@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 16, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (11)