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Cervical Dysplasia - ClinicalTrials.gov

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Last Updated: 07 September 2022

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Large Loop Excision of the Transformation Zone (LLETZ) With Versus Without Intraoperative Application of Lugol's Iodine in Women With Cervical Dysplasia: a Prospective Randomized Trial

According to epidemiological data, 85-91% of sexually active adults have at least one genital HPV infection by the age of 50, with 95% of HPV infections being spontaneously eradicated within two years in terms of HPV immunological clearance. HPV preferentially infects the epithelial cells of the anogenital region of the anogenital area, and, when left untreated, may progress into invasive cervical epithelium cancer. Cervical carcinoma is the fourth most common cancer and the fourth leading cause of cancer-related deaths in women globally, with 6. 6% of all new cancer cases and 7. 5% of cancer-related deaths in women in 2018. The occurrence of precancerous lesions of the cervix uteri is much greater than that of invasive cervical carcinoma. LLETZ is a common approach for performing LLETZ. The new S3 guideline by the German Society of Gynecology and Obstetrics on cervical dysplasia diagnosis and treatment also refers to intraoperative iodine testing as a potential alternative for performing LLETZ. Aim of the study The aim of this research is to determine whether LLETZ continued with the assistance of iodine assay in the iodine-positive zone, assay, under standard LLETZ without iodine assay.

Source link: https://clinicaltrials.gov/ct2/show/NCT05132114


Comparison of Two Surgical Approaches in the Treatment of Cervical Dysplasia: Complete Removal of the Transformation Zone (LLETZ) Versus Isolated Resection of the Colposcopically Visible Lesion (LEEP)

Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women around the world. There are four specific ways by which conization can be carried out in practice: Knife Conization, Laser Conization, Large Loop Excision of the Transformation Zone, and Loop Electrical Excision Procedure. Any increase in radicality may raise the complication rate of the procedure, especially in the case of the most feared long-term complication of preterm birth, since the more cervical tissue is removed, the higher the risk of subsequent preterm birth is increased. The present study was therefore intended to compare LLETZ with targeted resection of the colposcopically conspicuous lesion only and to compare it with respect to oncological safety. The first follow-up examination using PAP smear and HPV tests is carried out in accordance with the guidelines, following a delay of 6-8 months. In addition to the intra- and postoperative blood loss, the patient's experience, the intraoperative blood loss, and the incidence of negative high risk HPV tests after 6-8 months, studies have been consistently accepted as evidence of successful treatment. According, the negative predictive value for a negative HPV test after conization ranges from 92% to 100%.

Source link: https://clinicaltrials.gov/ct2/show/NCT04772937


Performance of Large Loop Excision of the Transformation Zone (LLETZ) in Women With Cervical Dysplasia in the Follicular Phase Versus the Luteal Phase of the Menstrual Cycle: a Prospective Randomized Trial

According to Epidemiologic studies, 85-91% of sexually active adults experience at least one genital HPV infection by the age of 50, with 85 percent of HPV infections being spontaneously eliminated within two years in terms of HPV immunological clearance. HPV preferentially infects the epithelial cells of the anogenital region, and initiates dysplastic changes in the cervical epithelium that, if left untreated, may progress into invasive cervix. Cervical carcinoma is the fourth most common cancer and the fourth leading cause of cancer-related deaths in women worldwide, accounting for 6. 6% of all new cancer cases and 7. 5% of cancer-related deaths in women in 2018. LLETZ conization is the internationally recognized surgical procedure for conization. Both the frequency of blood flow to reproductive organs and hemostasis are influenced by the impact of the menstrual cycle during and after conization. The amount of intraoperative and postoperative blood loss in two non-controlled, retrospective studies of patients undergoing mammary reduction surgery and rhinoplasty was lower during the follicular phase than during the luteal period. Women who underwent LLETZ conization in the luteal phase had significantly higher anxiety scores and assessed the surgery more negatively than women who underwent surgery during the follicular phase, according to a randomized study.

Source link: https://clinicaltrials.gov/ct2/show/NCT05391243


The Dynamic Process of Vaginal Microbiota and Mucosal Immunity After Focused Ultrasound Treatment of Cervical Intraepithelial Neoplasia Patients With Fertility Requirement

It is unclear if FUS, as a type of ablation treatment process, promotes the body's immune response to promote the reversal of the lesions by in situ necrotic lesions. The cervical tissues of patients with CIN before and after FUS therapy were examined, and after treatment, the expression of p16 and ki-67 decreased, but Fas increased, indicating that FUS can control cell proliferation and apoptosis-related proteins and cervical tissue repair. Zeng also compared the cervical immune microenvironment in patients with CIN with CIN before and after FUS therapy. In cervical tissue tissue, FUS treatment has increased the expression of ERAP1 in cervical tissue and reduced the amount of IgA and IL-10, which has shown that FUS therapy can regulate the cervical immune microenvironment. The local immunological indexes produced by FUS treatment of CIN should be a flexible process, and more time points should be selected to monitor the changes in these immunological indexes. At the same time, a large number of studies show that Vaginal Microbiota can change the cervicovaginal immune microenvironment and Lactobacillus spp. This interventional study was designed to analyze the effect of FUS ablation treatment of CIN and HPV clearance in patients with CIN before and after FUS ablation therapy, as well as untreated healthy controls.

Source link: https://clinicaltrials.gov/ct2/show/NCT05142397


A Two-Cohort Randomized Phase 2 Trial of the IRX-2 Regimen in Women With Squamous Cervical Intraepithelial Neoplasia 3 (CIN 3) or Vulvar Intraepithelial Neoplasia 3 (VIN 3)

To determine the toxicity and feasibility of IRX-2 in patients with confirmed cervical intraepithelial neoplasia 3 or 3. At weeks 6, 13 and 25, the occurrence of clinical CRs or PRs in multiple variables can be determined by multiple variables to determine the IRX-2 regimen for the treatment of CIN 3 or VIN 3: the occurrence of clinical CRs or PRs. Multiple parameters were used to determine the effectiveness of the IRX-2 regimen for the treatment of CIN 3 or VIN 3 infections of human papillomavirus in cervical or vulvar tissue using a commercial HPV genotyping kit and viral load determination by quantitative polymerase chain reaction. Multiple parameters were used to determine the effectiveness of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: the incidence of serum antibodies to HPV E6, E7, and L1 proteins by enzyme-linked immunosorbent assays. Multiple parameters were used to determine the IRX-2 regimen's effectiveness for the treatment of CIN 3 or VIN 3: ribonucleic acid expression profiling of immune-inflammatory markers from post-treatment resected surgical specimens. On days 1 and IRX-2, patients receive cyclophosphamide intravenously via submucosal injections in the cervix or subcutaneously for vulvar lesions. Arm I: Patients receive cyclophosphamide intravenously on day 1 and IRX-2. Patients on day 1 and placebo receive cyclophosphamide IV with submucosal injections in the cervix or SC for vulvar lesions on days 4-7.

Source link: https://clinicaltrials.gov/ct2/show/NCT03267680

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions