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

NCT05282095 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

OTHER

Follow up

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.

Sponsors & Collaborators

  • Fujian Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • Pengming Sun · Fujian Maternal and Child Health Hospital

Eligibility

Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282095 on ClinicalTrials.gov