Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-24 @ 5:07 AM
Study NCT ID:
NCT00528203
Status:
TERMINATED
Last Update Posted:
2016-07-12
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, Lymphocytes, Whole blood, RBC hemolysate, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3640}}, 'statusModule': {'whyStopped': 'Funds for study ended September 30, 2008.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2007-09-10', 'studyFirstSubmitQcDate': '2007-09-10', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'Sickle Cell Anemia', 'DNA'], 'conditions': ['Anemia, Sickle Cell']}, 'descriptionModule': {'briefSummary': 'Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.', 'detailedDescription': 'SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted.\n\nThis study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult and pediatric patients who are enrolled in the C-Data project are eligible for this study. (C-Data eligibility: All adult and pediatric patients who have been seen within the last 24 months in the hospital or clinical setting and are expected to return episodically or regularly for care at 1 of the CSCC are eligible for inclusion in the C-Data project.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating in the C-Data project\n\nExclusion Criteria:\n\n* Unable to undergo blood collection'}, 'identificationModule': {'nctId': 'NCT00528203', 'acronym': 'Gen/Phen', 'briefTitle': 'Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'officialTitle': 'Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository', 'orgStudyIdInfo': {'id': '517'}, 'secondaryIdInfos': [{'id': 'U54HL070587', 'link': 'https://reporter.nih.gov/quickSearch/U54HL070587', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94134', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10463', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina-Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Hospital of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern & Parkland', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Carolyn Hoppe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Carolyn Hoppe, MD', 'oldOrganization': "Children's Hospital Oakland"}}}}