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

NCT05282095 | Recruiting DMC

• 1 other identifier: HPVZHCIN22021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 20

Brief 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. 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.

Conditions

Cervical Intraepithelial Neoplasia; HPV Infection; Virus Integration; HSIL, High Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (19)

• 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 all participants.

  6-month follow-up

• Cervical histopathology testing at 12-month follow-up

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

  12-month follow-up

• Human Papillomavirus (HPV) viral integration test at baseline

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

  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.

  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.

  12-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 3-month follow-up

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

  3-month follow-up

• Cervical cytology testing at 6-month follow-up

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

  6-month follow-up

• Cervical cytology testing at 9-month follow-up

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

  9-month follow-up

• Cervical cytology testing at 12-month follow-up

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

  12-month follow-up

• 16SrRNA sequencing of the vaginal secretions at baseline

  All participants underwent vaginal secretion sequencing at baseline.

  Baseline

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

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

  3-month follow-up

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

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

  6-month follow-up

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

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

  9-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

  12-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 3-month follow-up

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

  3-month follow-up

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

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

  9-month follow-up

Study Arms (1)

Women aged from 18-45 with histopathologically confirmed CIN2

In 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.

Other: Follow up

Interventions

Follow up OTHER

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.

Women aged from 18-45 with histopathologically confirmed CIN2

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (20)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Longyan First Hospital

Longyan, Fujian, China

RECRUITING

The Second Hospital of Longyan

Longyan, Fujian, 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

The Affiliated Hospital of Putian University

Putian, Fujian, China

RECRUITING

Sanming Second Hospital

Sanming, Fujian, China

RECRUITING

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, 363000, China

RECRUITING

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, China

RECRUITING

Shenzhen Maternity and Child HealthCare Hospital

Shenzhen, Guangdong, China

RECRUITING

Guiyang maternal and child health care hospital

Guiyang, Guizhou, China

RECRUITING

Hubei Maternal and Child Health Care Hospital

Wuhan, Hubei, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Jiangxi maternal and Child Health Hospital

Nanchang, Jiangxi, China

RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40295124 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Officials

• Pengming Sun

  Fujian Maternal and Child Health Hospital

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

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

Pengming Sun

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: March 7, 2022
• First Posted: March 16, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (20)