Cervical DysplasiaPhase 1NCT06137950
Interferon Alpha Therapy for Cervical CINI and HPV Infection
A Phase 1 study testing gel Interferon arm and gel Interferon and interferon suppository arm in people with Cervical Dysplasia and HPV Infection, run by Mongolian National University of Medical Sciences at 1 site in Mongolia.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cervical Dysplasia, HPV Infection
- What is being tested?
- gel Interferon arm and gel Interferon and interferon suppository arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMongolia
- Study dates
- 7 Nov 2023to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pap smear LSIL
- HPV infection positive
- No anti-viral treatment in 2 weeks before treatment
Who cannot join
- No consent has obtained
- Anti-viral treatment in 2 weeks
- Breastfeeding or pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cervical Dysplasia, HPV Infection
- Being tested
- gel Interferon arm, gel Interferon and interferon suppository arm
- Keywords
- CIN I, HPV infection
- Medical subject headings
- Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gel Interferon armDrug
Also called Interferon alfa-2b low dose local treatment
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 armDrug
Also called Interferon alfa-2b low dose local and high dose systemic treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Interferon α2b gel treatment for 30 days. Receives: Drug: gel Interferon arm |
| Treatment | Experimental | Interferon α2b gel treatment for 30 days
+ Interferon α2b 3 MIU rectal suppository for 10 days Receives: Drug: gel Interferon arm; Drug: gel Interferon and interferon suppository arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pap smear
LSIL, HSIL or regression of the change will be assessed.
Measured: 90 days
Colposcopic change
Cervical changes before and after treatment will be compared.
Measured: 90 days
Secondary outcomes (2)
Histopathologic change
CINI, CINII or regression of the cervical dysplasia will be evaluated.
Measured: 90 days
Immunohistochemical change
Anti CD-3 and anti CD-19 staining will be done and stained cells will be calculated and compared.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Nov 2023
- Primary completion15 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongolian National University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mongolian National Cancer Center
- Responsible party
- Principal investigator, Batsuren Choijamts, Mongolian National University of Medical Sciences
- Investigators
- Batsuren Choijamts, Ph.D, Principal investigator, Mongolian National University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137950
- Sponsor's protocol ID
- MNUMS2021100701
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16485882Hoffman 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.
PubMed 28124442Shi 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.
PubMed 30213012Su 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.
PubMed 29044006
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Alpha Therapy for Cervical CIN I and HPV Infection
- ClinicalTrials.gov ID
- NCT06137950
- Acronym / sponsor ID
- MNUMS2021100701
- Conditions
- Cervical Dysplasia, HPV Infection
- Keywords
- CIN I, HPV infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mongolian National University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mongolian National Cancer Center
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: gel Interferon armInterferon α2b gel treatment for 30 days. |
| Treatment | Experimental | Drug: gel Interferon arm, Drug: gel Interferon and interferon suppository armInterferon α2b gel treatment for 30 days + Interferon α2b 3 MIU rectal suppository for 10 days |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pap smear LSIL
- HPV infection positive
- No anti-viral treatment in 2 weeks before treatment
Key exclusion criteria (3 listed)
- No consent has obtained
- Anti-viral treatment in 2 weeks
- Breastfeeding or pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gel Interferon armAlso: Interferon alfa-2b low dose local treatment0.2 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. | Drug | Control, Treatment |
| gel Interferon and interferon suppository armAlso: Interferon alfa-2b low dose local and high dose systemic treatment0.2 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. | Drug | Treatment |
Primary outcome
Pap smear
Time frame: 90 days
LSIL, HSIL or regression of the change will be assessed.
Colposcopic change
Time frame: 90 days
Cervical changes before and after treatment will be compared.
2 secondary outcomes
Histopathologic change
Time frame: 90 days
Immunohistochemical change
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 16485882Nestor 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.
- Background: PubMed 28124442Hoffman 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.
- Background: PubMed 30213012Shi 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.
- Background: PubMed 29044006Su 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batsuren Choijamts, Ph.D principal investigator
Mongolian National University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gel Interferon arm and gel Interferon and interferon suppository arm in people with Cervical Dysplasia and HPV Infection, run by Mongolian National University of Medical Sciences at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pap smear (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137950, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.