Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions
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|ClinicalTrials.gov Identifier: NCT03233412|
Recruitment Status : Active, not recruiting
First Posted : July 28, 2017
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|High Grade Intraepithelial Neoplasia Cervix Cancer||Procedure: Control Drug: Imiquimod||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients between 25 and 50 years old with histological diagnosis of high-grade intraepithelial lesion, obtained through satisfactory colposcopy and without previous treatment, who will be selected in the preventive clinic of the Hospital de Cancer de Barretos-SP (HCB ). Eligible patients will be identified at the return visit, when they will come to the hospital to check the result of the examination. In this study the patients will be randomized into two groups: Group 1: Control, where standard treatment will be offered, which is the conization of the uterine cervix with loop electrosurgical excision procedure(LEEP); Group 2: experimental group, which will receive topical treatment in the uterine cervix with immunomodulator (Imiquimod), for a period of 12 weeks, with weekly applications (1x / week). 30 to 60 days after immunomodulatory treatment the patient will be submitted to standard treatment with cervical conization with LEEP.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ensaio clínico Randomizado Avaliando a eficácia do Tratamento tópico Com Imiquimode em lesões Intraepiteliais Cervicais de Alto Grau|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||January 7, 2020|
Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
Exertion of the cervix transformation zone
Will receive topical uterine cervix (Imiquimod) treatment for a period of 12 weeks with weekly applications (1x / week). 30-60 days afterwards they will be submitted to standard treatment with conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
Exertion of the cervix transformation zone
Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
- Efficacy of immunomodulatory treatment with Imiquimod in high grade intraepithelial lesions of the cervix compared to standard electrosurgical excision procedure (LEEP) treatment. [ 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
- Local and systemic adverse events [ Time Frame: 30 months ]To assess the local and systemic adverse effects of topical immunomodulatory treatment through anamnesis and physical examination.
- Compare CIN 2 and CIN 3 for the difference in response to immunomodulatory treatment [ 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.
- Definition of the difference in cost from actual standard treatment compared to Imiquimod [ 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
- Evaluation of recurrence of high grade cervical squamous intraepithelial lesion after 2 years of treatment. [ Time Frame: 24 months ]To evaluate the recurrence after 2 years of the end of the immunomodulatory topical treatment.
- Evaluation of reoperation rate after immunomodulatory treatment associated with standard treatment with LEEP compared to LEEP alone. [ Time Frame: 24 months ]Evaluation of reoperation rate in post-treatment follow-up.
- Clearance HPV [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233412
|Barretos Cancer Hospital|
|Study Director:||Ricardo D Reis, PhD||Barretos Cancer Hospital|
|Principal Investigator:||Bruno DO Fonseca, MD||Barretos Cancer Hospital|