Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT06137950
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon Alpha Therapy for Cervical CINI and HPV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077190', 'term': 'Interferon alpha-2'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pap smear', 'timeFrame': '90 days', 'description': 'LSIL, HSIL or regression of the change will be assessed.'}, {'measure': 'Colposcopic change', 'timeFrame': '90 days', 'description': 'Cervical changes before and after treatment will be compared.'}], 'secondaryOutcomes': [{'measure': 'Histopathologic change', 'timeFrame': '90 days', 'description': 'CINI, CINII or regression of the cervical dysplasia will be evaluated.'}, {'measure': 'Immunohistochemical change', 'timeFrame': '90 days', 'description': 'Anti CD-3 and anti CD-19 staining will be done and stained cells will be calculated and compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CIN I, HPV infection'], 'conditions': ['Cervical Dysplasia', 'HPV Infection']}, 'referencesModule': {'references': [{'pmid': '16485882', 'type': 'BACKGROUND', '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.'}, {'pmid': '28124442', 'type': 'BACKGROUND', '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.'}, {'pmid': '30213012', 'type': 'BACKGROUND', '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.'}, {'pmid': '29044006', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b.\n\nMaterials 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.\n\nAt the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.', 'detailedDescription': 'The purpose of the study is to evaluate the efficacy of interferon treatment for HPV infection shedding and early CIN change.\n\nWomen 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.\n\nIn the beginning of the study all patient will have cervical pap smear and HPV typing.\n\nHPV 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).\n\nAt the beginning and at the end of the study all patient will have histology test.\n\nHistology 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.\n\nPap 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'This study is about treatment of uterine cervical dysplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pap smear LSIL\n* HPV infection positive\n* No anti-viral treatment in 2 weeks before treatment\n\nExclusion Criteria:\n\n* No consent has obtained\n* Anti-viral treatment in 2 weeks\n* Breastfeeding or pregnant'}, 'identificationModule': {'nctId': 'NCT06137950', 'briefTitle': 'Interferon Alpha Therapy for Cervical CINI and HPV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Mongolian National University of Medical Sciences'}, 'officialTitle': 'Interferon Alpha Therapy for Cervical CIN I and HPV Infection', 'orgStudyIdInfo': {'id': 'MNUMS2021100701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Interferon α2b gel treatment for 30 days.', 'interventionNames': ['Drug: gel Interferon arm']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Interferon α2b gel treatment for 30 days\n\n\\+ Interferon α2b 3 MIU rectal suppository for 10 days', 'interventionNames': ['Drug: gel Interferon arm', 'Drug: gel Interferon and interferon suppository arm']}], 'interventions': [{'name': 'gel Interferon arm', 'type': 'DRUG', 'otherNames': ['Interferon alfa-2b low dose local treatment'], 'description': '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.', 'armGroupLabels': ['Control', 'Treatment']}, {'name': 'gel Interferon and interferon suppository arm', 'type': 'DRUG', 'otherNames': ['Interferon alfa-2b low dose local and high dose systemic treatment'], 'description': '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.\n\n3MIU 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.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17011', 'city': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'overallOfficials': [{'name': 'Batsuren Choijamts, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mongolian National University of Medical Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongolian National University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mongolian National Cancer Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department', 'investigatorFullName': 'Batsuren Choijamts', 'investigatorAffiliation': 'Mongolian National University of Medical Sciences'}}}}