Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-28 @ 1:03 AM
Study NCT ID:
NCT01221766
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-27', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adnexal involvement', 'timeFrame': '1 year', 'description': 'To determine if adnexal involvement predicts worse severity and/or prognosis in chronic GVHD. This will be measured by administration of systemic therapy other than steroids.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adnexal', 'hair and nail', 'chronic graft vs host disease', 'children'], 'conditions': ['Graft vs Host Disease', 'Chronic Graft vs Host Disease', 'cGVHD']}, 'descriptionModule': {'briefSummary': 'This research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. We are interested in knowing if hair and nail problems predict worse disease. This information may help us treat patients like you in the future.', 'detailedDescription': "* At the initial visit, participants will have a complete examination of their skin, hair and nails. We will also test muscle strength and movement by moving the participant's arms, legs and neck. Photographs will be taken of the skin, hair and nails of they are abnormal. Blood tests will be done to check the liver and blood cell count. The participant and their legal guardian will answer questions about how the participant feels and about their health.\n* Participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. At each subsequent visit the following will be done: A complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The research subject population is children who have received hematopoietic stem cell transplant and developed chronic graft-versus-host disease. All children seen at the pediatric GVHD clinic at the Dana-Farber Cancer Institute will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Received hematopoietic stem cell transplant\n* Meet the diagnostic criteria for cutaneous cGVHD\n\nExclusion Criteria:\n\n* Previous HSCT (other then the current HSCT)'}, 'identificationModule': {'nctId': 'NCT01221766', 'briefTitle': 'Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'The Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease', 'orgStudyIdInfo': {'id': '10-163'}}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jennifer Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Dermatology', 'investigatorFullName': 'Jennifer Huang, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}