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

Sun Yat-sen University

Status: Unknown

Conditions: Cervical Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT05185713

SYSEC-KY-KS-2021-214

Details and patient eligibility

About

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.

Full description

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 group), high-grade squamous intraepithelial lesion (HSIL group) and newly diagnosed invasive cervical cancer (ICC group).

Obtain basic information through the questionnaire, and collect vaginal secretion and blood samples every time the patients review the clincal department as scheduled. 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.

Carry out the genital tract inflammation score calculating, blood inflammatory factors testing, biological information analyzing, and metabolite composition and content in vaginal secretions analyzing.

The purpose of this study is to 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 60 years women;
2. have a history of sexual life for 3 years or more;
3. women not in the menstrual period, pregnancy, or puerperium.

Exclusion criteria

1. Women who received antibiotics and antifungal treatment within one month before the sample collection (records);
2. Women suffering from the following diseases: other cancer, vaginal infections, bacterial vaginosis, vulvar infections, urinary tract infections or sexually transmitted infections including chlamydia, gonorrhea, trichomoniasis and genital herpes, type I or type II diabetes, AIDS Virus positive;
3. Women with abnormal vaginal secretions or dirt in the vagina, and women who used flushing substances within three weeks before the sample collection;
4. Have sexual intercourse or use vaginal lubricant within 48 hours before sample collection.

Trial design

300 participants in 5 patient groups

Ctrl HPV (-)

Description:

Patients with normal cervix and HPV negative

Treatment:

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

Ctrl HPV (+)

Description:

Patients with normal cervix and HPV positive

Treatment:

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

LSIL group

Description:

Patients with low-grade squamous Intraepithelial lesion

Treatment:

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

HSIL group

Description:

Patients with high-grade squamous Intraepithelial lesion

Treatment:

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

ICC group

Description:

Patients newly diagnosed invasive cervical cancer

Treatment:

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