Interferon Alpha Therapy for Cervical CINI and HPV Infection

HPV Infection Clinical Trial

Official title:

Interferon Alpha Therapy for Cervical CIN I and HPV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137950
• Other study ID #: MNUMS2021100701
• Status: Recruiting
• Phase: Phase 1
• Start date: November 7, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: November 2023
• Source: Mongolian National University of Medical Sciences
• Contact: Batsuren Choijamts, PhD
• Phone: 976-94044253
• Email: batsuren.ch[@]mnums.edu.mn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Communicable Diseases
• HPV Infection
• Infections
• Papillomavirus Infections
• Uterine Cervical Dysplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mongolia	National Cancer Center	Ulaanbaatar

Sponsors (2)

Lead Sponsor	Collaborator
Mongolian National University of Medical Sciences	Mongolian National Cancer Center

Country where clinical trial is conducted

Mongolia, 

References & Publications (4)

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. — View Citation

Nestor MS, Gold MH, Kauvar AN, Taub AF, Geronemus RG, Ritvo EC, Goldman MP, Gilbert DJ, Richey DF, Alster TS, Anderson RR, Bank DE, Carruthers A, Carruthers J, Goldberg DJ, Hanke CW, Lowe NJ, Pariser DM, Rigel DS, Robins P, Spencer JM, Zelickson BD. The use of photodynamic therapy in dermatology: results of a consensus conference. J Drugs Dermatol. 2006 Feb;5(2):140-54. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pap smear	LSIL, HSIL or regression of the change will be assessed.	90 days
Primary	Colposcopic change	Cervical changes before and after treatment will be compared.	90 days
Secondary	Histopathologic change	CINI, CINII or regression of the cervical dysplasia will be evaluated.	90 days
Secondary	Immunohistochemical change	Anti CD-3 and anti CD-19 staining will be done and stained cells will be calculated and compared.	90 days