Cervical Intraepithelial NeoplasiaNCT05142397
The Dynamic Process of VMB and Mucosal Immunity After FUS Treatment of CIN Patients With Fertility Requirement
An observational study of Cervical Intraepithelial Neoplasia, run by Shufang Chang at 1 site in China.
Trial summary
Cervical cancer is the fourth leading cause of cancer death in women worldwide, and cervical intraepithelial neoplasia (CIN) can progress to cervical cancer. Therefore, timely treatment of CIN is critical in preventing the occurrence of cervical cancer. 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 Intraepithelial Neoplasia
- What is being tested?
- Focused Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 30 Jun 2023
- 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: We plan to include women with HPV positive, who plan for focused ultrasound ablation treatment for CIN attending the colposcopy clinics at the Second Affiliated Hospital of Chongqing Medical University.
Who may be able to join
- patients aged 18-60 years old；
- patients who had sexual life；
- patients who had HPV infection;
- patients who apply to ablation therapy
- pathological report indicates CIN
Who cannot join
- pregnant or lactating women;
- patients who had cervical treatment ;
- patients who had genital tract infection ;
- patients who had chronic diseases, such as allergic diseases ，autoimmune diseases and so on；
- patients who received antibiotics or pessaries within 14 days of sampling.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Yan Peng, +8618896737132, Lam_PY@163.com
About this study
Official title: The Dynamic Process of Vaginal Microbiota and Mucosal Immunity After Focused Ultrasound Treatment of Cervical Intraepithelial Neoplasia Patients With Fertility Requirement
Cervical cancer is the fourth leading cause of cancer death in women worldwide, and cervical intraepithelial neoplasia (CIN) can progress to cervical cancer. Therefore, timely treatment of CIN is critical in preventing the occurrence of cervical cancer. With the implementation and promotion of the World Health Organization's 2030 Global Strategy for the Elimination of Cervical Cancer, an increasing number of women are detecting and treating CIN at an earlier stage. Common treatment methods include ablation treatment and excision treatment, but for women who are planning to have children, the risk of cervical insufficiency and pregnancy complications is greatly increased after excisional treatment, so ablation treatment seems to be a better choice.
Read the detailed description
Focused ultrasound (FUS) is a new ablation method for the treatment of CIN that has received a lot of attention because of its unique ablation mode (from inside to outside) and lack of smoke, ionizing radiation, and other side effects. Preliminary studies have found that FUS treatment is safe and effective at reversing CIN, with curative effects comparable to traditional ablation and excisional treatments. However, few studies have reported the mechanism of FUS in the treatment of CIN. As a kind of ablation treatment, it is unclear whether FUS, like other ablation treatment mechanisms, stimulates the immune response of the body to promote the reversal of the lesions by in situ necrotic lesions.
There is limited evidence to support the link between FUS, immune response, and CIN. Fu compared the cervical tissues of patients with CIN before and after FUS treatment and found that the expression of p16 and ki-67 decreased while the expression of Fas increased after treatment, indicating that FUS can regulate cell proliferation and apoptosis-related proteins, and promote the recovery of cervical tissues. More recently, Zeng compared the cervical immune microenvironment in patients with CIN before and after FUS treatment. It has shown that FUS treatment increased the expression of ERAP1 in cervical tissue and decreased the level of IgA and IL-10 in cervicovaginal lavage, which indicated that FUS treatment can regulate the cervical immune microenvironment.
The immune response of the body is a dynamic and changing process. Any attempt to infer further on immunological changes before and after treatment require dynamic studies that will explore how FUS ablation of the disease, i.e. CIN, will alter the cervical immune microenvironment. The local immunological indexes produced by FUS treatment of CIN should be a dynamic process, and more time points should be selected to monitor the changes in these immunological indexes. Currently, there are no such studies.
At the same time, a large number of studies suggest that Vaginal Microbiota(VMB) can alter the cervicovaginal immune microenvironment and Lactobacillus spp. depleted and high diversity of VMB is prone to form a pro-inflammatory environment, which in turn promotes the progression of CIN and the occurrence of cervical cancer. Therefore, to further explore the mechanisms of FUS ablation treatment of CIN and clearance of HPV, this interventional study was conducted to dynamically observe the changes in the VMB and mucosal immunity in patients with CIN before and after FUS ablation treatment and to compare with untreated healthy controls. This may also have implications for the persistence and recurrence of lesions.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Focused Ultrasound
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundProcedure or surgery
Also called High-Intensity Focused Ultrasound Ablation
Focused ultrasound generates heat effects, mechanical effects and cavitation effects that denature the diseased tissues, facilitate necrosis and allow them to be replaced by surrounding normal healthy tissues.
| Study group | Role | What they receive |
|---|---|---|
| Treated women | HPV positive，pathology result indicate cervical intraepithelial neoplasia Receives: Procedure: Focused Ultrasound | |
| Healthy controls | HPV negative, normal cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological indexes
Immunological indexes(IFN-γ、IL-8、IL-10、IL-1β、SIgA) in cervical secretions will be measured by enzyme-linked immunosorbent assay (ELISA).
Measured: We will get specimens in therapeutic day, after treatment 7-10 days，84-112days and 168-196 days respectively.
Anti-microbial peptides
Anti-microbial peptides levels (hBD-1、SLPI ) in cervical secretions will be measured by enzyme-linked immunosorbent assay (ELISA).
Measured: We will get specimens in therapeutic day, after treatment 7-10 days，84-112 days and 168-196 days respectively.
Vaginal microbiota
We will evaluate vaginal microbiota by bacterial diversity and richness, and Lactobacillus grading.
Measured: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
HPV genotyping
HPV DNA testing and genotyping
Measured: We will get specimens before therapeutic day, after 84-112 days and 168-196 days respectively.
Cytology
Thinprep cytologic test
Measured: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
Secondary outcomes (2)
Measurement of dimensions of cervix
Transvaginal ultrasonography is performed to measure the dimensions of cervix.
Measured: We will measure the dimensions of cervix before therapeutic day and after treatment 84-112 days respectively.
Antisperm antibody
Antisperm antibody in cervical secretions will be measured by enzyme-linked immunosorbent assay (ELISA).
Measured: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shufang Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shufang Chang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Shu F Chang, professor, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142397
- Sponsor's protocol ID
- shfch2005
- Status last verified
- Aug 2022
- First submitted
- 3 Nov 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamic Process of Vaginal Microbiota and Mucosal Immunity After Focused Ultrasound Treatment of Cervical Intraepithelial Neoplasia Patients With Fertility Requirement
- ClinicalTrials.gov ID
- NCT05142397
- Acronym / sponsor ID
- shfch2005
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shufang ChangUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Dec 2021 (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.
Cervical cancer is the fourth leading cause of cancer death in women worldwide, and cervical intraepithelial neoplasia (CIN) can progress to cervical cancer. Therefore, timely treatment of CIN is critical in preventing the occurrence of cervical cancer. With the implementation and promotion of the World Health Organization's 2030 Global Strategy for the Elimination of Cervical Cancer, an increasing number of women are detecting and treating CIN at an earlier stage. Common treatment methods include ablation treatment and excision treatment, but for women who are planning to have children, the risk of cervical insufficiency and pregnancy complications is greatly increased after excisional treatment, so ablation treatment seems to be a better choice.
Detailed description
Focused ultrasound (FUS) is a new ablation method for the treatment of CIN that has received a lot of attention because of its unique ablation mode (from inside to outside) and lack of smoke, ionizing radiation, and other side effects. Preliminary studies have found that FUS treatment is safe and effective at reversing CIN, with curative effects comparable to traditional ablation and excisional treatments. However, few studies have reported the mechanism of FUS in the treatment of CIN. As a kind of ablation treatment, it is unclear whether FUS, like other ablation treatment mechanisms, stimulates the immune response of the body to promote the reversal of the lesions by in situ necrotic lesions.
There is limited evidence to support the link between FUS, immune response, and CIN. Fu compared the cervical tissues of patients with CIN before and after FUS treatment and found that the expression of p16 and ki-67 decreased while the expression of Fas increased after treatment, indicating that FUS can regulate cell proliferation and apoptosis-related proteins, and promote the recovery of cervical tissues. More recently, Zeng compared the cervical immune microenvironment in patients with CIN before and after FUS treatment. It has shown that FUS treatment increased the expression of ERAP1 in cervical tissue and decreased the level of IgA and IL-10 in cervicovaginal lavage, which indicated that FUS treatment can regulate the cervical immune microenvironment.
The immune response of the body is a dynamic and changing process. Any attempt to infer further on immunological changes before and after treatment require dynamic studies that will explore how FUS ablation of the disease, i.e. CIN, will alter the cervical immune microenvironment. The local immunological indexes produced by FUS treatment of CIN should be a dynamic process, and more time points should be selected to monitor the changes in these immunological indexes. Currently, there are no such studies.
At the same time, a large number of studies suggest that Vaginal Microbiota(VMB) can alter the cervicovaginal immune microenvironment and Lactobacillus spp. depleted and high diversity of VMB is prone to form a pro-inflammatory environment, which in turn promotes the progression of CIN and the occurrence of cervical cancer. Therefore, to further explore the mechanisms of FUS ablation treatment of CIN and clearance of HPV, this interventional study was conducted to dynamically observe the changes in the VMB and mucosal immunity in patients with CIN before and after FUS ablation treatment and to compare with untreated healthy controls. This may also have implications for the persistence and recurrence of lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated women | – | Procedure: Focused UltrasoundHPV positive，pathology result indicate cervical intraepithelial neoplasia |
| Healthy controls | – | –HPV negative, normal cytology |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We plan to include women with HPV positive, who plan for focused ultrasound ablation treatment for CIN attending the colposcopy clinics at the Second Affiliated Hospital of Chongqing Medical University.
Key inclusion criteria (5 listed)
- patients aged 18-60 years old；
- patients who had sexual life；
- patients who had HPV infection;
- patients who apply to ablation therapy
- pathological report indicates CIN
Key exclusion criteria (5 listed)
- pregnant or lactating women;
- patients who had cervical treatment ;
- patients who had genital tract infection ;
- patients who had chronic diseases, such as allergic diseases ，autoimmune diseases and so on；
- patients who received antibiotics or pessaries within 14 days of sampling.
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 |
|---|---|---|
| Focused UltrasoundAlso: High-Intensity Focused Ultrasound AblationFocused ultrasound generates heat effects, mechanical effects and cavitation effects that denature the diseased tissues, facilitate necrosis and allow them to be replaced by surrounding normal healthy tissues. | Procedure or surgery | Treated women |
Primary outcome
Immunological indexes
Time frame: We will get specimens in therapeutic day, after treatment 7-10 days，84-112days and 168-196 days respectively.
Immunological indexes(IFN-γ、IL-8、IL-10、IL-1β、SIgA) in cervical secretions will be measured by enzyme-linked immunosorbent assay (ELISA).
Anti-microbial peptides
Time frame: We will get specimens in therapeutic day, after treatment 7-10 days，84-112 days and 168-196 days respectively.
Anti-microbial peptides levels (hBD-1、SLPI ) in cervical secretions will be measured by enzyme-linked immunosorbent assay (ELISA).
Vaginal microbiota
Time frame: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
We will evaluate vaginal microbiota by bacterial diversity and richness, and Lactobacillus grading.
HPV genotyping
Time frame: We will get specimens before therapeutic day, after 84-112 days and 168-196 days respectively.
HPV DNA testing and genotyping
Cytology
Time frame: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
Thinprep cytologic test
2 secondary outcomes
Measurement of dimensions of cervix
Time frame: We will measure the dimensions of cervix before therapeutic day and after treatment 84-112 days respectively.
Antisperm antibody
Time frame: We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- 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.
Shu F Chang, professor principal investigator
The Second Affiliated Hospital of Chongqing Medical 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 Intraepithelial Neoplasia, run by Shufang Chang 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 5 inclusion and 5 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 18 Aug 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 Yan Peng (+8618896737132, Lam_PY@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological indexes (time frame: We will get specimens in therapeutic day, after treatment 7-10 days，84-112days and 168-196 days respectively.). The study lists 5 primary outcomes in all. 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 18 Aug 2022.