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The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer

NCT05185713 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-01-25

No results posted yet for this study

Summary

The disorder of vaginal microflora and its metabolites is considered to be a facilitating factor to human papillomavirus-mediated cervical cancer. However, the mechanism is still unclear. This study intends to carry out a cross-sectional study and a cohort study. The cross-sectional study intends to recruit 300 premenopausal non-pregnant women, dividing them into five groups, with 60 in each group: HPV negative \[Ctrl HPV (-)\], HPV positive \[Ctrl HPV (+)\], low-grade squamous Intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) and newly diagnosed invasive cervical cancer (ICC). Obtain basic information through the questionnaire, and collect vaginal secretion and blood samples. At the same time, patients who are diagnosed with cervical cancer for the first time will be included in the cohort study. Collect the same kind of information. The follow-up period is set to be 3 years, and samples will be collected every six months. If any condition changes within the 3 years, samples should be collected. If new treatments are taken, samples should be taken before and after treatment. And if the lesion turns negative after treatment within the 3 years, complete the follow-up. Using 16S rRNA gene sequencing, metabolomics, and immunological methods to determine the vaginal microbiota and its metabolites and inflammation condition, select biomarkers related to the onset of cervical cancer. construct a cervical cancer risk model and outcome prediction model, and reveal the mechanism of vaginal flora and its metabolites in the pathogenesis and development of cervical cancer. Therefore provides a new direction for the prevention and treatment of cervical cancer.

Conditions

Interventions

OTHER

This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.

This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Rao Qunxian · The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • China

Study Locations

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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 NCT05185713 on ClinicalTrials.gov