The Vaginal Microecology and Innate Immunity After Focused Ultrasound Ablation Treatment for CIN

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Brief Title

The Vaginal Microecology and Innate Immunity After Focused Ultrasound Ablation Treatment for CIN

Official Title

The Vaginal Microecology and Innate Immunity After Focused Ultrasound Ablation Treatment for Cervical Intraepithelial Neoplasia

Brief 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.
    

Detailed 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-γ is mainly involved in cellular immune
      response.Th2 type cytokines(IL-1β、IL-8、IL-10) are mainly inducing humoral immune response and
      inhibiting cellular immune response. The increased expression of IFN-γcontributes 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-γ 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-1β 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.
    


Study Type

Observational


Primary Outcome

Cytokine profile

Secondary Outcome

 Measurement of dimensions of cervix

Condition

Cervical Intraepithelial Neoplasia

Intervention

Focused Ultrasound

Study Arms / Comparison Groups

 Treated women
Description:  HPV positive,pathology result indicate cervical intraepithelial neoplasia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

August 15, 2021

Completion Date

June 30, 2023

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. patients aged 18-60 years old;

          2. patients who had sexual life;

          3. patients who had HPV infection;

          4. patients who apply to ablation therapy

          5. pathological report indicates CIN

        Exclusion Criteria:

          1. pregnant or lactating women;

          2. patients who had cervical treatment ;

          3. patients who had genital tract infection ;

          4. patiants who had chronic diseases, such as allergic diseases ,autoimmune diseases and
             so on.
      

Gender

Female

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shu F Chang, professor, 008618896737132, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05142397

Organization ID

shfch2005


Responsible Party

Sponsor-Investigator

Study Sponsor

Shufang Chang


Study Sponsor

Shu F Chang, professor, Principal Investigator, The Second Affiliated Hospital of Chongqing Medical University


Verification Date

November 2021