Interferon Alpha Therapy for Cervical CINI and HPV Infection

• Status: Recruiting
• Trial end date: 2024-09-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mongolian National University of Medical Sciences
• Collaborator: Mongolian National Cancer Center
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

Criteria

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