Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05185713
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2021-12-07
Brief Title:
The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None