Barretos Cancer Hospital
Barretos, Brazil
NCT Number: NCT03233412
Cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human Papillomavirus) infection. The female organism most often is able to eliminate the virus, especially in young patients. However, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused interest in seeking alternative therapies. Decrease antiviral activity directed against HPV, associated with a higher rate of elimination of the infection. Immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial T cells. Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better scientific compilation. Based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.
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Notify Me25 year–50 year
Female
Interventional
Phase 2
Barretos, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exertion of the cervix transformation zone
Other names: loop electrosurgical excision procedure, Conization of the cervix
Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
Other names: Imiquimod 5% cream, Ixium 5%
Time frame: 30 months
We will evaluate the efficacy of the Imiquimod treatment applied by the physician after histological examination of the uterine cervix obtained by electrosurgical excision procedure (LEEP) and compare the rate of relapse / reoperation with the control patient only submitted to the standard treatment with LEEP
Time frame: 30 months
To assess the local and systemic adverse effects of topical immunomodulatory treatment through anamnesis and physical examination.
Time frame: 30 months
It will be evaluated separately from the results of the treatment response with Imiquimod in CIN 2 and CIN 3 lesions.
Time frame: 30 months
The value in Brazilian reais of treatment with Imiquimod will be defined as compared to the amount spent for the standard treatment with LEEP
Time frame: 24 months
To evaluate the recurrence after 2 years of the end of the immunomodulatory topical treatment.
Time frame: 24 months
Evaluation of reoperation rate in post-treatment follow-up.
Time frame: 30 months
To evaluate the persistence or not of the HPV virus and which specific type to relate to the efficacy of the immunomodulatory treatment.
Barretos Cancer Hospital
Other
Ensaio clínico Randomizado Avaliando a eficácia do Tratamento tópico Com Imiquimode em lesões Intraepiteliais Cervicais de Alto Grau
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