Interferon Alpha Therapy for Cervical CINI and HPV Infection

March 31, 2025 updated by: Batsuren Choijamts, Mongolian National University of Medical Sciences

Interferon Alpha Therapy for Cervical CIN I 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia, 17011
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Interferon α2b gel treatment for 30 days.
Drug: gel Interferon arm
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
Experimental: Treatment

Interferon α2b gel treatment for 30 days

+ Interferon α2b 3 MIU rectal suppository for 10 days
Drug: gel Interferon arm
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
Drug: gel Interferon and interferon suppository arm

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathologic change
Time Frame: 90 days
CINI, CINII or regression of the cervical dysplasia will be evaluated.
90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mongolian National University of Medical Sciences

Collaborators

Mongolian National Cancer Center

Investigators

  • Principal Investigator: Batsuren Choijamts, Ph.D, Mongolian National University of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNUMS2021100701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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