The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
NCT ID: NCT05185713
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2022-04-01
2023-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Ctrl HPV (-)
Patients with normal cervix and HPV negative
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.
Ctrl HPV (+)
Patients with normal cervix and HPV positive
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.
LSIL group
Patients with low-grade squamous Intraepithelial lesion
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.
HSIL group
Patients with high-grade squamous Intraepithelial lesion
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.
ICC group
Patients newly diagnosed invasive cervical cancer
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. have a history of sexual life for 3 years or more;
3. women not in the menstrual period, pregnancy, or puerperium.
Exclusion Criteria
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.
18 Years
60 Years
FEMALE
Yes
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Rao Qunxian
Role: STUDY_DIRECTOR
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Hinkula M, Pukkala E, Kyyronen P, Laukkanen P, Koskela P, Paavonen J, Lehtinen M, Kauppila A. A population-based study on the risk of cervical cancer and cervical intraepithelial neoplasia among grand multiparous women in Finland. Br J Cancer. 2004 Mar 8;90(5):1025-9. doi: 10.1038/sj.bjc.6601650.
Syrjanen S, Shabalova I, Petrovichev N, Kozachenko V, Zakharova T, Pajanidi J, Podistov J, Chemeris G, Sozaeva L, Lipova E, Tsidaeva I, Ivanchenko O, Pshepurko A, Zakharenko S, Nerovjna R, Kljukina L, Erokhina O, Branovskaja M, Nikitina M, Grujnberga V, Grujnberg A, Juschenko A, Johansson B, Tosi P, Cintorino M, Santopietro R, Syrjanen K. Sexual habits and human papillomavirus infection among females in three New Independent States of the former Soviet Union. Sex Transm Dis. 2003 Sep;30(9):680-4. doi: 10.1097/01.OLQ.0000079519.04451.D4.
Moreno V, Bosch FX, Munoz N, Meijer CJ, Shah KV, Walboomers JM, Herrero R, Franceschi S; International Agency for Research on Cancer. Multicentric Cervical Cancer Study Group. Effect of oral contraceptives on risk of cervical cancer in women with human papillomavirus infection: the IARC multicentric case-control study. Lancet. 2002 Mar 30;359(9312):1085-92. doi: 10.1016/S0140-6736(02)08150-3.
Lee SA, Kang D, Seo SS, Jeong JK, Yoo KY, Jeon YT, Kim JW, Park NH, Kang SB, Lee HP, Song YS. Multiple HPV infection in cervical cancer screened by HPVDNAChip. Cancer Lett. 2003 Aug 20;198(2):187-92. doi: 10.1016/s0304-3835(03)00312-4.
Patterson JL, Stull-Lane A, Girerd PH, Jefferson KK. Analysis of adherence, biofilm formation and cytotoxicity suggests a greater virulence potential of Gardnerella vaginalis relative to other bacterial-vaginosis-associated anaerobes. Microbiology (Reading). 2010 Feb;156(Pt 2):392-399. doi: 10.1099/mic.0.034280-0. Epub 2009 Nov 12.
Gonzalez A, Navas-Molina JA, Kosciolek T, McDonald D, Vazquez-Baeza Y, Ackermann G, DeReus J, Janssen S, Swafford AD, Orchanian SB, Sanders JG, Shorenstein J, Holste H, Petrus S, Robbins-Pianka A, Brislawn CJ, Wang M, Rideout JR, Bolyen E, Dillon M, Caporaso JG, Dorrestein PC, Knight R. Qiita: rapid, web-enabled microbiome meta-analysis. Nat Methods. 2018 Oct;15(10):796-798. doi: 10.1038/s41592-018-0141-9. Epub 2018 Oct 1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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SYSEC-KY-KS-2021-214
Identifier Type: -
Identifier Source: org_study_id
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