Clinical trial · Observational
The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Ctrl HPV (-)
- description
- Patients with normal cervix and HPV negative
- interventionNames
- Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
- label
- Ctrl HPV (+)
- description
- Patients with normal cervix and HPV positive
- interventionNames
- Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
- label
- LSIL group
- description
- Patients with low-grade squamous Intraepithelial lesion
- interventionNames
- Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDBray 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. PMID 30207593
- BACKGROUNDHinkula 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. PMID 14997202
- BACKGROUNDSyrjanen 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. PMID 12972789
- BACKGROUNDMoreno 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. PMID 11943255
- BACKGROUNDLee 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. PMID 12957357
- BACKGROUNDPatterson 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.