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Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03233412
Recruitment Status : Active, not recruiting
First Posted : July 28, 2017
Last Update Posted : July 23, 2019
Farmoquimica S.A.
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
High Grade Intraepithelial Neoplasia Cervix Cancer Procedure: Control Drug: Imiquimod Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
Procedure: Control
Exertion of the cervix transformation zone
Other Names:
  • loop electrosurgical excision procedure
  • Conization of the cervix

Experimental: Imiquimod
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).
Procedure: Control
Exertion of the cervix transformation zone
Other Names:
  • loop electrosurgical excision procedure
  • Conization of the cervix

Drug: Imiquimod
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%

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women between the ages of 25 and 50 with histological diagnosis of CIN 2/3;
  • Living 300 km or less from the city of Barretos-São Paulo / Brazil.

Exclusion Criteria:

  • Suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology;
  • Being pregnant or breastfeeding;
  • Women with some immunodeficiency or transplanted;
  • Previous treatment history for CIN 2/3.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03233412

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Barretos Cancer Hospital
Barretos, Brazil
Sponsors and Collaborators
Barretos Cancer Hospital
Farmoquimica S.A.
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Study Director: Ricardo D Reis, PhD Barretos Cancer Hospital
Principal Investigator: Bruno DO Fonseca, MD Barretos Cancer Hospital

Publications of Results:
International Agency for Research on Cancer, World Health Organization, Globocan, Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012

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Responsible Party: Barretos Cancer Hospital Identifier: NCT03233412    
Other Study ID Numbers: BarretosCH-20171
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barretos Cancer Hospital:
high grade cervical intraepithelial neoplasia
Immunomodulatory treatment
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers