Interferon Alpha Therapy for Cervical CINI and HPV Infection

Study Overview
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Brief Summary
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Mongolia is a traditionally nomadic and population is scarce in rural areas. Thus, the medical care service is not sufficient. In 2000, Mongolian government has developed and implemented the millennium project in cooperation with WHO. During the years pap smear analysis of implemented in all rural areas and clinicians, lab technicians have been taught for the cervical cancer screening. However, the project has finished in 2015 and the rural and district hospitals has lost the trained professionals. Still the cervical cancer is in second place after liver cancer in women. The purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b. Materials and methods: HPV positive patients will be enrolled to the study. HPV genotype will be determined by the PCR in laboratory. Pap smear will be taken and staged by the CIN. Pathological tissue will be taken under colposcopy with acetic acid test. Follow up visit will be done on 10th, 30th days of the treatment. At the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.

Detailed Description
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The purpose of the study is to evaluate the efficacy of interferon treatment for HPV infection shedding and early CIN change. Women aging from 20-40 years will be enrolled in the study. The treatment will be held in two arms. One arm will be administered only vaginal gel interferon treatment. The other arm will receive both vaginal gel interferon and rectal suppositories with interferon dosing 3,000,000 IU. In the beginning of the study all patient will have cervical pap smear and HPV typing. HPV testing will be done using real time PCR method to determine the subtype of HPV (16,18,31,33,35,39,45,51,52,56,59,68). At the beginning and at the end of the study all patient will have histology test. Histology test will be done Giemsa staining and evaluated by WHO 2014 classification of cervical histology including CINI, CINII, CINIII, cervical cancer in situ and further. Pap smear will be evaluated by Bethesda classification. Immunohistology staining will be done on the cervical tissue using anti-CD3 and anti-CD19 to evaluate the B cell invasion into the cervix.

Official Title
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Interferon Alpha Therapy for Cervical CIN I and HPV Infection

Conditions
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Cervical Dysplasia, HPV Infection

Intervention / Treatment
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* Drug: gel Interferon arm
* Drug: gel Interferon and interferon suppository arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pap smear LSIL HPV infection positive No anti-viral treatment in 2 weeks before treatment Exclusion Criteria: No consent has obtained Anti-viral treatment in 2 weeks Breastfeeding or pregnant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Interferon α2b gel treatment for 30 days. | Drug: gel Interferon arm<br>* 0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days.<br>* Other names: Interferon alfa-2b low dose local treatment;|
| Experimental: Treatment<br>Interferon α2b gel treatment for 30 days + Interferon α2b 3 MIU rectal suppository for 10 days | Drug: gel Interferon arm<br>* 0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days.<br>* Other names: Interferon alfa-2b low dose local treatment;Drug: gel Interferon and interferon suppository arm<br>* 0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days. 3MIU suppository will be given to patients and will be trained how to use. Each patient in the arm will use the suppository twice a day for 10 days with vaginal therapy.<br>* Other names: Interferon alfa-2b low dose local and high dose systemic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pap smear | LSIL, HSIL or regression of the change will be assessed. | 90 days | 
| Colposcopic change | Cervical changes before and after treatment will be compared. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathologic change | CINI, CINII or regression of the cervical dysplasia will be evaluated. | 90 days | 
| Immunohistochemical change | Anti CD-3 and anti CD-19 staining will be done and stained cells will be calculated and compared. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIN I, HPV infection