Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 8:01 PM
Study NCT ID:
NCT01808495
Status:
UNKNOWN
Last Update Posted:
2015-08-13
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Function and Modulation of Fibulin-1 Assembly in Nucleus of Corneal Fibroblasts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2013-03-08', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of nuclear Fibulin-1 accumulation in suppressing gene expression', 'timeFrame': '3 days post mitomycin C treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human corneal fibroblasts', 'Fibulin-1', 'Nuclear accumulation'], 'conditions': ['Function of Mitomycin C in Cornea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human Corneal Fibroblasts under treatment of mitomycin C (MMC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The original cell sources were collected from the donors with more than 20 years old following penetrating keratoplasty. After successfully amplified from the residual corneal rim following penetrating keratoplasty in the previous projects, human corneal fibroblasts (HCFs) were reserved in liquid nitrogen tank and were thawed for this study under in vitro cultivation and application.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty.\n\nExclusion Criteria:\n\n* The donors were younger than 20 years old.'}, 'identificationModule': {'nctId': 'NCT01808495', 'briefTitle': 'Function and Modulation of Fibulin-1 Assembly in Nucleus of Corneal Fibroblasts', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'orgStudyIdInfo': {'id': 'FEMH-IRB-101002-F'}, 'secondaryIdInfos': [{'id': 'NSC101-2320-B-418-002', 'type': 'OTHER_GRANT', 'domain': 'NSC101-2320-B-418-002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Mitomycin C', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tsan-Chi Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Ophthalmology', 'investigatorFullName': 'Tsan-Chi Chen', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}