Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 6:50 AM
Study NCT ID:
NCT03846856
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2019-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Involvement of IGF Axis in Ovarian Cancer', 'timeFrame': 'Two years', 'description': 'Ovarian cancer specimens taken during surgical procedures will be evaluated and analyzed by flow cytometry assays to determine the involvement of the IGF axis in the immune tumor microenvironment in ovarian cancer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with epithelium ovarian cancer who have undergone or who plan to undergo surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed with epithelium ovarian cancer who have undergone surgery\n\nExclusion Criteria:\n\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03846856', 'briefTitle': 'The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance', 'orgStudyIdInfo': {'id': 'HYMC-0080-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ovarian cancer patients', 'description': 'Biopsy will be taken from ovarian cancer patients and sent to laboratory for analysis', 'interventionNames': ['Other: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'OTHER', 'description': 'Biopsy taken during surgical procedure', 'armGroupLabels': ['Ovarian cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Hagit Stolz, DVM', 'role': 'CONTACT', 'email': 'hagitst@hy.health.gov.il', 'phone': '972-7744335'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Hagit Stolz, DVM', 'role': 'CONTACT', 'email': 'hagitst@hy.health.gov.il', 'phone': '972-4-7744335'}], 'overallOfficials': [{'name': 'Ilan Bruchim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}