Cervical CancerNCT06859151
DNA Methylation and the Increased Risk of Cervical Cancer Development
An observational study of Cervical Cancer and Papillomavirus Infections, run by Zhujiang Hospital.
Trial summary
This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Papillomavirus Infections
- What is being tested?
- Reproductive tract microbiota
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women aged 18 to 50
Who may be able to join
- Aged 18-50 years old, with a history of sexual activity
- HPV and TCT tests are performed concurrently in the gynecology clinic
- Those with abnormal HPV and TCT test results undergo tissue pathological testing
Who cannot join
- Pregnant or breastfeeding
- Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE
- Those who have had organ transplants or are currently using immunosuppressive agents
- Use of vaginal douching within 48 hours before sample collection
- Use of vaginal probiotics within one month before sample collection
- Use of vaginal antibiotics or antifungal treatments within one month before sample collection
- History of surgery related to cervical intraepithelial neoplasia (CIN), including but not limited to conization of the cervix, LEEP procedures, etc.
- Blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development
This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study
Read the detailed description
This study is a multicenter matched case-control study. The inclusion and exclusion criteria are verified by collecting HPV test results, TCT examination results, and for the case group, participants' histopathological results are also collected. Participants who meet the inclusion and exclusion criteria have their HPV DNA test original secretion samples and TCT examination original cervical scrape cell samples (preserved in RNA preservative solution) collected. Enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. The discovery cohort undergoes multi-target DNA methylation testing, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing; the validation cohort undergoes PCR validation of DNA methylation sites related to cervical cancer, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing
- Conditions
- Cervical Cancer, Papillomavirus Infections
- Being tested
- Reproductive tract microbiota
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive tract microbiotaOther
Reproductive tract microbiota
| Study group | Role | What they receive |
|---|---|---|
| control | HPV16(-) HPV18(-) TCT(-) Receives: Other: Reproductive tract microbiota | |
| Case group 1 | HPV16(+) /HPV18(+) TCT(-) CIN<2 Receives: Other: Reproductive tract microbiota | |
| Case group 2 | HPV16(+) /HPV18(+) TCT(+) CIN<2 Receives: Other: Reproductive tract microbiota | |
| Case group 3 | HPV16(+) /HPV18(+) TCT(+) CIN≥2+ Receives: Other: Reproductive tract microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DNA methylation of cervical epithelial cells
Changes in DNA methylation of cervical epithelial cells
Measured: Baseline (enrollment period)
Secondary outcomes (1)
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens.
Measured: Baseline (enrollment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muxuan Chen, Zhujiang Hospital
- Investigators
- Muxuan Chen, Doctor, Principal investigator, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859151
- Sponsor's protocol ID
- CALM2501
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development
- ClinicalTrials.gov ID
- NCT06859151
- Acronym / sponsor ID
- CALM2501
- Conditions
- Cervical Cancer, Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study
Detailed description
This study is a multicenter matched case-control study. The inclusion and exclusion criteria are verified by collecting HPV test results, TCT examination results, and for the case group, participants' histopathological results are also collected. Participants who meet the inclusion and exclusion criteria have their HPV DNA test original secretion samples and TCT examination original cervical scrape cell samples (preserved in RNA preservative solution) collected. Enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. The discovery cohort undergoes multi-target DNA methylation testing, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing; the validation cohort undergoes PCR validation of DNA methylation sites related to cervical cancer, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: Reproductive tract microbiotaHPV16(-) HPV18(-) TCT(-) |
| Case group 1 | – | Other: Reproductive tract microbiotaHPV16(+) /HPV18(+) TCT(-) CIN<2 |
| Case group 2 | – | Other: Reproductive tract microbiotaHPV16(+) /HPV18(+) TCT(+) CIN<2 |
| Case group 3 | – | Other: Reproductive tract microbiotaHPV16(+) /HPV18(+) TCT(+) CIN≥2+ |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women aged 18 to 50
Key inclusion criteria (3 listed)
- Aged 18-50 years old, with a history of sexual activity
- HPV and TCT tests are performed concurrently in the gynecology clinic
- Those with abnormal HPV and TCT test results undergo tissue pathological testing
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding
- Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE
- Those who have had organ transplants or are currently using immunosuppressive agents
- Use of vaginal douching within 48 hours before sample collection
- Use of vaginal probiotics within one month 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 |
|---|---|---|
| Reproductive tract microbiotaReproductive tract microbiota | Other | Case group 1, Case group 2, Case group 3, control |
Primary outcome
Changes in DNA methylation of cervical epithelial cells
Time frame: Baseline (enrollment period)
Changes in DNA methylation of cervical epithelial cells
1 secondary outcome
Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens
Time frame: Baseline (enrollment period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Muxuan Chen, Doctor principal investigator
Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Papillomavirus Infections, run by Zhujiang Hospital.
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 8 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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muxuan Chen, Doctor (+8613580561916, muxuanchen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DNA methylation of cervical epithelial cells (time frame: Baseline (enrollment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.