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Completed

NCT Number: NCT06137950

Interferon Alpha Therapy for Cervical CINI and HPV Infection

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.

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Key information

Conditions

Cervical Dysplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HPV Infection Infections Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center

Ulaanbaatar, 17011, Mongolia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gel Interferon arm

Drug

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.

Other names: Interferon alfa-2b low dose local treatment

gel Interferon and interferon suppository arm

Drug

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.

Other names: Interferon alfa-2b low dose local and high dose systemic treatment

Primary outcomes

  1. Pap smear

    Time frame: 90 days

    LSIL, HSIL or regression of the change will be assessed.

  2. Colposcopic change

    Time frame: 90 days

    Cervical changes before and after treatment will be compared.

Secondary outcomes

  1. Histopathologic change

    Time frame: 90 days

    CINI, CINII or regression of the cervical dysplasia will be evaluated.

  2. Immunohistochemical change

    Time frame: 90 days

    Anti CD-3 and anti CD-19 staining will be done and stained cells will be calculated and compared.

Sponsors and collaborators

Lead sponsor

Mongolian National University of Medical Sciences

Other

Collaborators

  • Mongolian National Cancer Center

Registry information

Official study title

Interferon Alpha Therapy for Cervical CIN I and HPV Infection

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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