Clinical trial NCT06137950: Interferon Alpha Therapy for Cervical CINI and HPV Infection
Official title: Interferon Alpha Therapy for Cervical CIN I and HPV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Dysplasia
HPV Infection
Keywords: CIN I, HPV infection
Lead sponsor: Mongolian National University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mongolian National Cancer Center
First posted: 2023-11-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pap smear
timeFrame: 90 days
measure: Colposcopic change
timeFrame: 90 days
Secondary outcomes:
measure: Histopathologic change
timeFrame: 90 days
measure: Immunohistochemical change
timeFrame: 90 days
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: National Cancer Center
Study officials:
affiliation: Mongolian National University of Medical Science
name: Batsuren Choijamts, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hoffman SR, Le T, Lockhart A, Sanusi A, Dal Santo L, Davis M, McKinney DA, Brown M, Poole C, Willame C, Smith JS. Patterns of persistent HPV infection after treatment for cervical intraepithelial neoplasia (CIN): A systematic review. Int J Cancer. 2017 Jul 1;141(1):8-23. doi: 10.1002/ijc.30623. Epub 2017 Feb 27.
citation: Shi HJ, Song H, Zhao QY, Tao CX, Liu M, Zhu QQ. Efficacy and safety of combined high-dose interferon and red light therapy for the treatment of human papillomavirus and associated vaginitis and cervicitis: A prospective and randomized clinical study. Medicine (Baltimore). 2018 Sep;97(37):e12398. doi: 10.1097/MD.0000000000012398.
citation: Su Y, Zhang M, Zhang W, Shi H. Clinical efficacy of cryotherapy combined with interferon in the treatment of chronic cervicitis complicated with HPV infection. Pak J Pharm Sci. 2017 Jul;30(4(Suppl.)):1505-1508.