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

NCT05142397 | Unknown DMC

• 1 other identifier: shfch2005
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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.

  We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.

• HPV genotyping

  HPV DNA testing and genotyping

  We will get specimens before therapeutic day, after 84-112 days and 168-196 days respectively.

• Cytology

  Thinprep cytologic test

  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

  We will measure the dimensions of cervix before therapeutic day and after treatment 84-112 days respectively.

• Antisperm antibody

  We will get specimens before therapeutic day, after treatment 84-112 days and 168-196 days respectively.

Study Arms (2)

Treated women

HPV positive，pathology result indicate cervical intraepithelial neoplasia

Procedure: Focused Ultrasound

Healthy controls

HPV negative, normal cytology

Interventions

Focused Ultrasound PROCEDURE

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.

Also known as: High-Intensity Focused Ultrasound Ablation

Treated women

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shufang Chang: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical secretions、Vaginal microbiota、HPV genotyping、Thinprep cytologic test

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Shu F Chang, professor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Peng

CONTACT

+8618896737132; Lam_PY@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 2, 2021
• Study Start: August 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CN (1)