Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:57 AM
Study NCT ID:
NCT07379905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* ARM A: Control Arm for Wait-and-See approach\n* ARM B: Intervation Arm for MODUCARE oral capsules, dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-25', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regression rate of CIN1', 'timeFrame': '6 months after randomization'}], 'secondaryOutcomes': [{'measure': 'Regression rate of CIN1', 'timeFrame': '12 months after randomization'}, {'measure': 'Progression rate of CIN1', 'timeFrame': '6 & 12 months after randomization'}, {'measure': 'Treatment related adverse events', 'timeFrame': ': 6 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low-grade Cervical Intraepithelial Neoplasia', 'Moducare']}, 'descriptionModule': {'briefSummary': 'MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1).', 'detailedDescription': 'Human Papillomavirus (HPV) is causally associated with cervical cancer and precancerous lesions (dysplasias) of the cervix. These lesions are detected mainly in the transformation zone and are diagnosed with colposcopy and biopsy confirmation. In high-grade lesions conization (surgical removal of a cone tissue form the cervix) is the therapy of choice, but in low-grade lesions monitoring and no-treatment is preferred. However, this wait-and-see approach can be assisted by pharmaceutical treatment, like MODUCARE.\n\nMODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources. It is taken orally, 2 capsules three times daily for the first month and then 1 capsule three times daily for next 5 months (in total 6 months).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven CIN1\n* Any HPV status (negative, positive: high or low risk)\n* Any Pap test result\n* Age 18 - 85 years old\n* ECOG Performance status 0 - 1\n\nExclusion Criteria:\n\n* Pregnancy\n* Low likelihood of patient compliance to treatment protocol and follow-up\n* Previous operation to the cervix\n* Previous pelvic malignancy\n* Pre-existing histologically proven CIN1 \\> 12 months\n* Pre-existing histologically proven CIN2 and/or CIN3\n* Hypersensitivity to trial medication'}, 'identificationModule': {'nctId': 'NCT07379905', 'acronym': 'MODUCIN1', 'briefTitle': 'MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)', 'orgStudyIdInfo': {'id': '2025-Β2015-518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'ARM A: Control Arm', 'description': 'Wait-and-See approach'}, {'type': 'EXPERIMENTAL', 'label': 'ARM B: Intervention Arm', 'description': 'MODUCARE oral capsules., dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)', 'interventionNames': ['Dietary Supplement: MODUCARE']}], 'interventions': [{'name': 'MODUCARE', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources.', 'armGroupLabels': ['ARM B: Intervention Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dimitrios Zouzoulas, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'dzouzoulas@hotmail.gr', 'phone': '+306946536065'}], 'overallOfficials': [{'name': 'Dimitrios Tsolakidis, Dr.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'INPA S.A.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecological Oncologist, MSc, PhD, FEBS-BS', 'investigatorFullName': 'Dimitrios Zouzoulas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}