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NCT Number: NCT05282095

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

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HPV Infection HSIL, High Grade Squamous Intraepithelial Lesions Infections Morphological and Microscopic Findings Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Intraepithelial Lesions Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases Virus Integration

Age range

Up to 45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, China

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About this study

This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);

Treatment and study plan

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.

Primary outcomes

  1. Cervical histopathology testing at baseline

    Time frame: Baseline

    Cervical histopathology was performed at baseline for all participants.

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

    Time frame: 6-month follow-up

    Cervical histopathology was performed at 6-month follow-up for all participants.

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

    Time frame: 12-month follow-up

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

  4. Human Papillomavirus (HPV) viral integration test at baseline

    Time frame: Baseline

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

  5. 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.

  6. 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.

  7. Cervical cytology testing at baseline

    Time frame: Baseline

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

  8. Cervical cytology testing at 3-month follow-up

    Time frame: 3-month follow-up

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

  9. 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

  10. Cervical cytology testing at 9-month follow-up

    Time frame: 9-month follow-up

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

  11. 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

  12. 16SrRNA sequencing of the vaginal secretions at baseline

    Time frame: Baseline

    All participants underwent vaginal secretion sequencing at baseline.

  13. 16SrRNA sequencing of the vaginal secretions at 3-month follow-up

    Time frame: 3-month follow-up

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

  14. 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

  15. 16SrRNA sequencing of the vaginal secretions at 9-month follow-up

    Time frame: 9-month follow-up

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

  16. 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

  17. Human Papillomavirus (HPV) genotyping tests at baseline

    Time frame: Baseline

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

  18. Human Papillomavirus (HPV) genotyping tests at 3-month follow-up

    Time frame: 3-month follow-up

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

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

    Time frame: 9-month follow-up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Binhua Dong

CONTACT

[email protected]

+86-591-87558732

Pengming Sun

CONTACT

[email protected]

+86-591-87558732

Sponsors and collaborators

Lead sponsor

Fujian Maternity and Child Health Hospital

Other

Registry information

Official study title

Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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