Interferon Alpha Therapy for Cervical CIN I and HPV Infection
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pap smear
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
Interferon α2b gel treatment for 30 days.
Intervention: gel Interferon arm (Drug)
Treatment
Interferon α2b gel treatment for 30 days
- Interferon α2b 3 MIU rectal suppository for 10 days
Intervention: gel Interferon arm (Drug)
Treatment
Interferon α2b gel treatment for 30 days
- Interferon α2b 3 MIU rectal suppository for 10 days
Intervention: gel Interferon and interferon suppository arm (Drug)
Outcomes
Primary Outcomes
Pap smear
Time Frame: 90 days
LSIL, HSIL or regression of the change will be assessed.
Colposcopic change
Time Frame: 90 days
Cervical changes before and after treatment will be compared.
Secondary Outcomes
- Histopathologic change(90 days)
- Immunohistochemical change(90 days)
Investigators
Batsuren Choijamts
Head of department
Mongolian National University of Medical Sciences