Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-04 @ 4:11 PM
Study NCT ID:
NCT01108159
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2010-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Whole-Genome Analysis of Hematologic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, bone marrow, skin biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression', 'timeFrame': 'sample collection at time of routine visit'}]}, 'conditionsModule': {'conditions': ['Hematologic Diseases']}, 'referencesModule': {'references': [{'pmid': '23872309', 'type': 'DERIVED', 'citation': 'Merker JD, Roskin KM, Ng D, Pan C, Fisk DG, King JJ, Hoh R, Stadler M, Okumoto LM, Abidi P, Hewitt R, Jones CD, Gojenola L, Clark MJ, Zhang B, Cherry AM, George TI, Snyder M, Boyd SD, Zehnder JL, Fire AZ, Gotlib J. Comprehensive whole-genome sequencing of an early-stage primary myelofibrosis patient defines low mutational burden and non-recurrent candidate genes. Haematologica. 2013 Nov;98(11):1689-96. doi: 10.3324/haematol.2013.092379. Epub 2013 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is to analyze all of the genes in the diseased and normal skin sample. By comparing the results of the diseased sample and normal skin cells and the results of the two types of genetic information (DNA and RNA), we should be able to identify genetic changes that are important for the initiation, progression, or treatment response of that particular disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'participants with hematologic disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. Patient meets the clinical and/or pathologic criteria for the hematologic disorder being examined.\n3. Patient is willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.\n\nExclusion Criteria:\n\n1. Less than 18 years of age\n2. Patient is not willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.'}, 'identificationModule': {'nctId': 'NCT01108159', 'briefTitle': 'Integrated Whole-Genome Analysis of Hematologic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Integrated Whole-Genome Analysis of Hematologic Disorders Using High-Throughput Sequencing and Array Technologies', 'orgStudyIdInfo': {'id': 'HEM0013'}, 'secondaryIdInfos': [{'id': '1081737-100-DHAAT'}, {'id': 'SU-09092009-3820', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': '16329', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood Draw', 'type': 'PROCEDURE'}, {'name': 'Skin Biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'James L Zehnder', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pathology', 'investigatorFullName': 'Jason D. Merker', 'investigatorAffiliation': 'Stanford University'}}}}