A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL

NCT05282745 | Unknown DMC

• 1 other identifier: PVLHCF
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 10

Brief Summary

Human papillomavirus (HPV) infection has become one of the most important health problems faced by women all over the world. A large number of studies have shown that women's cervical, vaginal and perianal precancerous lesions, related cancers, condyloma acuminatum and other sexually transmitted diseases (STD) are closely related to HPV infection. Among them, the persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types (such as type-16, -18, -39 and -52) on different levels of cervical lesions, and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions. In addition, other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 / CIN3 high-grade cervical lesions, and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion (LSIL) and cervical high-grade squamous intraepithelial lesion (HSIL). The above biological changes such as HPV infection type, quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees. It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening.

Conditions

HPV Infection; HSIL, High-Grade Squamous Intraepithelial Lesions; Viral Load

Outcome Measures

Primary Outcomes (16)

• 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 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 HPV infection or cytology abnormalities women.

  12-month follow-up

• Cervical histopathology testing at 24-month follow-up

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

  24-month follow-up

• Human Papillomavirus (HPV) viral load test at baseline

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

  Baseline

• Human Papillomavirus (HPV) viral load test at 6-month follow-up

  All participants were tested for HPV viral load at the time of 6-month follow-up.

  6-month follow-up

• Human Papillomavirus (HPV) viral load test at 12-month follow-up

  All participants were tested for HPV viral load at the time of 12-month follow-up.

  12-month follow-up

• Human Papillomavirus (HPV) viral load test at 24-month follow-up

  All participants were tested for HPV viral load at the time of 24-month follow-up.

  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 24-month follow-up

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

  24-month follow-up

• 16SrRNA sequencing of the vaginal secretions at baseline

  All participants underwent vaginal secretion sequencing at baseline.

  Baseline

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

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

  6-month follow-up

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

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

  12-month follow-up

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

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

  24-month follow-up

Secondary Outcomes (4)

• Human Papillomavirus (HPV) genotyping tests at baseline

  Baseline

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

  6-month follow-up

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

  12-month follow-up

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

  24-month follow-up

Study Arms (1)

Women with high-grade squamous intraepithelial lesion (HSIL) in cervix

In the enrollment, women whose cervical histopathological results have been diagnosed as high-grade squamous intraepithelial lesion (HSIL) for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months,12 months and 24 months.

Other: Follow-up

Interventions

Follow-up OTHER

Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.

Women with high-grade squamous intraepithelial lesion (HSIL) in cervix

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese women aged 20 and over with high-grade squamous intraepithelial lesion in results of cervical histopathology.

You may qualify if:

• Women aged 20 and over.
• The result of cervical histopathology in the last 3 months was high-grade squamous intraepithelial lesion (HSIL).
• Non pregnant people with sexual history.
• 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 (10)

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

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

RECRUITING

Longyan First Hospital

Longyan, China

RECRUITING

Shenzhen Maternity and child Healthcare Hospital

Shenzhen, China

RECRUITING

Maternity and child Hospital of Hubei Province

Wuhan, China

RECRUITING

Xiamen Maternity and Child Health Hospital

Xiamen, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples from cervix and vaginal fornix \& cell samples from cervix

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

• Pengming Sun, PhD

  Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• 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: December 15, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (10)