The Dynamic Process of VMB and Mucosal Immunity After FUS Treatment of CIN Patients With Fertility Requirement

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    90
  • sponsor
    Shufang Chang
Updated on 4 October 2022
cancer
cryotherapy
cancer screening
hpv vaccine
cervical disease
cervical cancer screening
hpv infection
Accepts healthy volunteers

Summary

With the popularization of cervical cancer screening more and more patients of cervical intraepithelial lesions have been found. The liberalization of the three child fertility policy also makes the treatment of patients with cervical intraepithelial lesions to retain cervical anatomic and physiological function become a trend. Compared with traditional ablation methods, focused ultrasound has good tissue penetration and controllable focused characteristics.Preliminary studies have shown that focused ultrasound is no less effective than traditional cryotherapy in the treatment of cervical intraepithelial lesions. However, as a new treatment method, the impact of focused ultrasound on cervical anatomic and physiological function is not clear. At the same time, it is unclear whether focused ultrasound ablation treatment for cervical intraepithelial lesions will stimulate immune response to HPV. Although the role of cytokines and vaginal microecology in cervical disease has been studied, the interaction between vaginal microecology, HPV and mucosal immunity is not completely clear.Therefore, this study is aimed at investigating the vaginal microecology and local cervical micro-environment for focused ultrasound ablation in the management of cervical intraepithelial neoplasia.This will provide a new and noninvasive method for the ablation of cervical intraepithelial lesions.

Description

Studies have shown that the mucus secreted by cervical mucosa is the main physical barrier against HPV. HPV can invade through locally damaged cervical mucosa that stimulate the body's non-specific immunity and specific immune response to resist the invasion of the virus.The specific cellular immune response plays a major role in resisting virus proliferation and inhibiting tumor progression. When pathogens invade, DCs are greatly activated. After activated by the antigen peptide presented by DCs, CD4 helper T-cells differentiate into Th1 and Th2 effector subsets.A Th1 type cytokine IFN- is mainly involved in cellular immune response.Th2 type cytokines(IL-1IL-8IL-10) are mainly inducing humoral immune response and inhibiting cellular immune response. The increased expression of IFN-contributes to the clearance of high-risk HPV. It may be a prognostic marker for the clearance of high-risk HPV in local cervical lesions. The down-regulation of IFN- and the up-regulation of IL-10 are considered to be one of the mechanisms of HPV escaping from the host immune system, which can produce a local immunosuppressive environment and inhibit the anti-tumor function. According to The Human Protein Atlas, IL-1 and IL-8 are unfavorable prognostic marker in cervical cancer, and the expression of them increased in the local cervical lesion with the progression of cervical intraepithelial neoplasia lesions. The occurrence of humoral immune response is later than cellular immune response.Th2 cells can promote the proliferation of B Cells and induce local reproductive tract mucosa to secrete IgA.In addition, studies have reported that HPV related IgA are mainly produced in HPV persistent infection.

Persistent HPV infection is the main factor in the progression of cervical lesions and the occurrence of cervical cancer, but only a few HPV infected women developing cervical cancer, which indicates that other factors may affect the occurrence of cervical cancer. The diversity of vaginal microecology is related to HPV infection, cervical lesions and cervical cancer. According to a new study, the surgical excision of cervical lesions can not alter vaginal microbiota composition.It appears more plausible that women with CIN have inherent genetic, epigenetic and environmental factors that shape vaginal microecology composition before and after treatment. However, it is certain that Lactobacillus can promote HPV clearance and the reversal of cervical lesions. Relevant studies indicate Lactobacillus inhibit the proliferation of HeLa cells.

This prospective observational study of women planned for local cervical treatment aims to explore the impact of the ablation of disease on the vaginal microecology and innate immune, and further explore how these pre- and post-treatments compare to healthy untreated controls.

Details
Condition cervical intraepithelial neoplasms, Cervical Intraepithelial Neoplasia
Treatment Focused Ultrasound
Clinical Study IdentifierNCT05142397
SponsorShufang Chang
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

pregnant or lactating women
patients who had cervical treatment
patients who had genital tract infection
patiants who had chronic diseases, such as allergic diseases autoimmune diseases and so on
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note