Viewing Study NCT01030159


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Study NCT ID: NCT01030159
Status: COMPLETED
Last Update Posted: 2014-04-09
First Post: 2009-12-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: National Cancer Institute Thai Cancer Anemia Survey
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients that have anemia during cancer therapy', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer Anemia Survey', 'Thai National Cancer Institute'], 'conditions': ['Anemia', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.', 'detailedDescription': 'Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anemic patients with cancer receiving chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cancer\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01030159', 'briefTitle': 'National Cancer Institute Thai Cancer Anemia Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag Ltd.,Thailand'}, 'officialTitle': 'Anemia Survey in Cancer Patients Study', 'orgStudyIdInfo': {'id': 'CR012703'}, 'secondaryIdInfos': [{'id': 'TCAS-NCI-ONCO-2006'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'interventionNames': ['Other: Adult Cancer Patients']}], 'interventions': [{'name': 'Adult Cancer Patients', 'type': 'OTHER', 'description': 'Tracking anemia management in Adult Cancer Patients', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Janssen-Cilag Ltd Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag Ltd.,Thailand', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}