Cervical CancerNCT05185713
The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
An observational study of Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jan 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients are selected from the gynecology clinical department of the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Who may be able to join
- Age 18 to 60 years women;
- have a history of sexual life for 3 years or more;
- women not in the menstrual period, pregnancy, or puerperium.
Who cannot join
- Women who received antibiotics and antifungal treatment within one month before the sample collection (records);
- 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;
- Women with abnormal vaginal secretions or dirt in the vagina, and women who used flushing substances within three weeks before the sample collection;
- Have sexual intercourse or use vaginal lubricant within 48 hours before sample collection.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Rao Qunxian, +86 13902250700, raoqx3@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
- Keywords
- cervical cancer, vaginal flora, metaboliomics
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Other
This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Ctrl HPV (-) | Patients with normal cervix and HPV negative Receives: Other: 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 Receives: Other: 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 Receives: Other: 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 Receives: Other: 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 Receives: Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genital tract inflammation score
ELISA kit is used to detect the expression levels of 7 cytokines (IL-1α, IL-1β, IL-8, MIP-1β, CCL20, RANTES and TNF-α, etc.) in the vaginal secretions, and determine a cumulative score according to the level of each cytokine. If 3 or more than 3 of the 7 cytokines ranks in the upper quartile of all participants, it's considered high-level reproductive tract inflammation. A score of 5 to 7 is considered high-grade genital tract inflammation, 1 to 5 is low-grade genital tract inflammation, and a score of 0 is no inflammation.
Measured: immediately after the sample collection
Blood inflammatory factors
Use ELISA kit to detect 7 kinds of inflammatory factors (IL-1α, IL-1β, IL-8, MIP-1β, CCL20, RANTES and TNF-α.) in the blood sample.
Measured: immediately after the sample collection
16sDNA sequencing and biological information analysis
Extract DNA with a total bacterial DNA extraction kit, using bacterial DNA as a template, bacterial 16S rDNA V3~V4 variable regions as targets, and barcode-equipped universal primers for PCR amplification. The PCR products will be sequenced using Illumina NovaSeq sequencing technology. After quality control, trimming, denoising, splicing, and chimera removal of the obtained raw data and reads, the high-throughput original base sequence is obtained, and the data will be analyzed using Qiime2 software. Data analysis includes operational unit (OTU) clustering, genetic enrichment analysis, principal component analysis (PCoA), community structure diversity (α and β diversity), and analysis of bacterial genus differences between groups (using linear discriminant effect analysis of LefSe ), correlation analysis, intestinal flora prediction model (random forest model).
Measured: immediately after the sample collection
The metabolite composition and content in vaginal secretions
The non-targeted metabolomics method is used to detect the metabolite composition and content in vaginal secretions. Quantitative analysis of metabolomics in each group, principal component analysis (PCOA, group analysis), differential metabolite spectrum analysis (increased/decreased metabolites in each group), correlation analysis (correlation analysis of inflammatory factors and metabolites). Correlation analysis between microbiology and metabolomics (including correlation analysis between different species and different metabolites, Scatter plot analysis, etc).
Measured: immediately after the sample collection
Secondary outcomes (1)
The content of the questionnaire
The content of the questionnaire includes:
- General information: name, place of origin, age, nationality, occupation, education level, family income, etc.
- Marriage and childbirth history: menstruation, marital status, pregnancy and parity, history of sexual life, contraceptive methods, etc.
- Lifestyle: smoking history, drinking history, sleep time, moderate to high-intensity physical activity, etc.
- Disease history and family history: diabetes, hypertension, venereal history, history of gynecological tumors.
- Testing and laboratory examinations: height, weight, gynecological examinations, HPV testing, TCT or cervical pathological diagnosis, etc.
Measured: immediately after the first visit of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rao Qunxian, Study director, The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185713
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-214
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30207593Hinkula 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.
PubMed 14997202Syrjanen 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.
PubMed 12972789Moreno 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.
PubMed 11943255Lee 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.
PubMed 12957357Patterson 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.
PubMed 19910411Gonzalez 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.
PubMed 30275573
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Vaginal Flora and Its Metabolites in the Pathogenesis of Cervical Cancer
- ClinicalTrials.gov ID
- NCT05185713
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-214
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, vaginal flora, metaboliomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ctrl HPV (-) | – | Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Patients with normal cervix and HPV negative |
| Ctrl HPV (+) | – | Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Patients with normal cervix and HPV positive |
| LSIL group | – | Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Patients with low-grade squamous Intraepithelial lesion |
| HSIL group | – | Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Patients with high-grade squamous Intraepithelial lesion |
| ICC group | – | Other: This project is a clinical observational study. No additional medication or surgical interventions are performed on the subjects.Patients newly diagnosed invasive cervical cancer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients are selected from the gynecology clinical department of the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Key inclusion criteria (3 listed)
- Age 18 to 60 years women;
- have a history of sexual life for 3 years or more;
- women not in the menstrual period, pregnancy, or puerperium.
Key exclusion criteria (4 listed)
- Women who received antibiotics and antifungal treatment within one month before the sample collection (records);
- 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;
- Women with abnormal vaginal secretions or dirt in the vagina, and women who used flushing substances within three weeks before the sample collection;
- Have sexual intercourse or use vaginal lubricant within 48 hours before sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Ctrl HPV (+), Ctrl HPV (-), HSIL group, ICC group, LSIL group |
Primary outcome
Genital tract inflammation score
Time frame: immediately after the sample collection
ELISA kit is used to detect the expression levels of 7 cytokines (IL-1α, IL-1β, IL-8, MIP-1β, CCL20, RANTES and TNF-α, etc.) in the vaginal secretions, and determine a cumulative score according to the level of each cytokine. If 3 or more than 3 of the 7 cytokines ranks in the upper quartile of all participants, it's considered high-level reproductive tract inflammation. A score of 5 to 7 is considered high-grade genital tract inflammation, 1 to 5 is low-grade genital tract inflammation, and a score of 0 is no inflammation.
Blood inflammatory factors
Time frame: immediately after the sample collection
Use ELISA kit to detect 7 kinds of inflammatory factors (IL-1α, IL-1β, IL-8, MIP-1β, CCL20, RANTES and TNF-α.) in the blood sample.
16sDNA sequencing and biological information analysis
Time frame: immediately after the sample collection
Extract DNA with a total bacterial DNA extraction kit, using bacterial DNA as a template, bacterial 16S rDNA V3~V4 variable regions as targets, and barcode-equipped universal primers for PCR amplification. The PCR products will be sequenced using Illumina NovaSeq sequencing technology. After quality control, trimming, denoising, splicing, and chimera removal of the obtained raw data and reads, the high-throughput original base sequence is obtained, and the data will be analyzed using Qiime2 software. Data analysis includes operational unit (OTU) clustering, genetic enrichment analysis, principal component analysis (PCoA), community structure diversity (α and β diversity), and analysis of bacterial genus differences between groups (using linear discriminant effect analysis of LefSe ), correlation analysis, intestinal flora prediction model (random forest model).
The metabolite composition and content in vaginal secretions
Time frame: immediately after the sample collection
The non-targeted metabolomics method is used to detect the metabolite composition and content in vaginal secretions. Quantitative analysis of metabolomics in each group, principal component analysis (PCOA, group analysis), differential metabolite spectrum analysis (increased/decreased metabolites in each group), correlation analysis (correlation analysis of inflammatory factors and metabolites). Correlation analysis between microbiology and metabolomics (including correlation analysis between different species and different metabolites, Scatter plot analysis, etc).
1 secondary outcome
The content of the questionnaire
Time frame: immediately after the first visit of the patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 14997202Hinkula 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.
- Background: PubMed 12972789Syrjanen 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.
- Background: PubMed 11943255Moreno 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.
- Background: PubMed 12957357Lee 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.
- Background: PubMed 19910411Patterson 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.
- Background: PubMed 30275573Gonzalez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rao Qunxian study director
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rao Qunxian (+86 13902250700, raoqx3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genital tract inflammation score (time frame: immediately after the sample collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185713, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.