Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-28 @ 7:25 AM
Study NCT ID:
NCT00442195
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12-04', 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2007-02-28', 'studyFirstSubmitQcDate': '2007-02-28', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain blood, bone marrow, and skin punch biopsy samples and/or buccal mucosa samples from subjects seeking to participate as healthy volunteers in NIH laboratory research studies.', 'timeFrame': 'Ongoing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Procurement', 'Sample Collection', 'Biologic Samples', 'Laboratory Research Specimens', 'Natural History'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '26529255', 'type': 'DERIVED', 'citation': 'Traba J, Kwarteng-Siaw M, Okoli TC, Li J, Huffstutler RD, Bray A, Waclawiw MA, Han K, Pelletier M, Sauve AA, Siegel RM, Sack MN. Fasting and refeeding differentially regulate NLRP3 inflammasome activation in human subjects. J Clin Invest. 2015 Nov 3;125(12):4592-600. doi: 10.1172/JCI83260.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2007-H-0113.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.\n\nHealthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:\n\n* Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.\n* Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.\n* Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.', 'detailedDescription': 'The purpose of this protocol is to collect and analyze blood (ages 8 and older), bone marrow (ages 18 and older), skin tissue samples (ages 18 and older), and/or buccal mucosa samples (ages 8 and older) from healthy volunteers. Samples will be used for clinical and translational research in the NHLBI and are indispensable for many of our research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia. This protocol provides a mechanism for collection, tracking, storing, dispensing, analyzing and disposing of these laboratory research samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nSelf-declared healthy volunteer (for blood and buccal mucosa sample donors).\n\nBe healthy, as determined by Principal Investigator or designee based on recent (\\<3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).\n\n\\<TAB\\>\\<TAB\\>\\<TAB\\>\\<TAB\\>\\<TAB\\>\n\nAge 8 years and older (no upper limit) for blood and buccal mucosa sampling.\n\nOR\n\nAges 18 years or older (no upper limit) for bone marrow or skin tissue sampling.\n\nEXCLUSION CRITERIA:\n\nUnable to comprehend the investigational nature of the protocol participation.\n\nCBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).\n\nPregnancy\n\nAge less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.\n\nOff campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.'}, 'identificationModule': {'nctId': 'NCT00442195', 'briefTitle': 'Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Procurement and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers to Support Clinical and Translational Research Projects in the NHLBI', 'orgStudyIdInfo': {'id': '070113'}, 'secondaryIdInfos': [{'id': '07-H-0113'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Healthy Volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'NIH Clinical Center Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'OPR Office of Patient Recruitment', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '(800) 411-1222'}], 'overallOfficials': [{'name': 'Neal S Young, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}