Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00890435
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2009-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'C531673', 'term': 'Familial ependymoma'}, {'id': 'D020339', 'term': 'Optic Nerve Glioma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D003397', 'term': 'Craniopharyngioma'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D054429', 'term': 'Leukemia, Myelomonocytic, Juvenile'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019574', 'term': 'Optic Nerve Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between study questionnaire answers and patient demographics', 'timeFrame': 'Length of study'}, {'measure': 'Correlation between study questionnaire answers and time required by pharmacokinetic sampling', 'timeFrame': 'Length of study'}, {'measure': 'Correlation between study questionnaire answers and the need for additional IV', 'timeFrame': 'Length of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'unspecified childhood solid tumor, protocol specific', 'recurrent childhood brain stem glioma', 'recurrent childhood cerebellar astrocytoma', 'recurrent childhood cerebral astrocytoma', 'recurrent childhood medulloblastoma', 'recurrent childhood supratentorial primitive neuroectodermal tumor', 'recurrent childhood ependymoma', 'recurrent childhood pineoblastoma', 'recurrent childhood subependymal giant cell astrocytoma', 'recurrent childhood visual pathway and hypothalamic glioma', 'recurrent childhood acute lymphoblastic leukemia', 'recurrent childhood acute myeloid leukemia', 'childhood choroid plexus tumor', 'childhood craniopharyngioma', 'childhood ependymoblastoma', 'childhood medulloepithelioma', 'childhood meningioma', 'childhood mixed glioma', 'childhood oligodendroglioma', 'adult astrocytic tumors', 'adult brain stem glioma', 'adult choroid plexus tumor', 'adult craniopharyngioma', 'adult ependymoblastoma', 'adult medulloblastoma', 'adult supratentorial primitive neuroectodermal tumor (PNET)', 'adult ependymal tumors', 'adult meningeal tumor', 'adult mixed glioma', 'adult oligodendroglial tumors', 'adult pineal parenchymal tumor', 'recurrent adult brain tumor', 'relapsing chronic myelogenous leukemia', 'recurrent adult acute lymphoblastic leukemia', 'recurrent adult acute myeloid leukemia', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(15;17)(q22;q12)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'secondary acute myeloid leukemia', 'acute undifferentiated leukemia', 'mast cell leukemia', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'T-cell large granular lymphocyte leukemia', 'refractory chronic lymphocytic leukemia', 'childhood chronic myelogenous leukemia', 'chronic myelomonocytic leukemia', 'juvenile myelomonocytic leukemia', 'refractory hairy cell leukemia', 'prolymphocytic leukemia'], 'conditions': ['Brain and Central Nervous System Tumors', 'Leukemia', 'Unspecified Adult Solid Tumor, Protocol Specific', 'Unspecified Childhood Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.\n\nPURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.', 'detailedDescription': 'OBJECTIVES:\n\n* To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.\n\nOUTLINE: This is a multicenter study.\n\nPatients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.\n\nPatient demographics and other relevant information are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A patient (family) who has consented to participate in a Phase I trial.', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients or their parents/guardians (if patient is a minor) consented to participate in a phase I treatment clinical trial with an optional pharmacokinetic (PK) component, within the past 4 weeks\n\n * Must not have withdrawn consent for the phase I treatment study\n\n * Patients or their parents/guardians are eligible regardless of whether they initially agreed to participate in the PK sampling\n\n * Must not withdraw consent for PK sampling prior to completing the study questionnaire if initially agreed to optional PK sampling\n * Patients or their parents/guardians are eligible regardless of whether they actually completed PK sampling (provided reasons for not completing the sampling was not withdrawal of the initial consent to the phase I treatment study)\n\nPATIENT CHARACTERISTICS:\n\n* Not cognitively or physically impaired\n* May participate no more than once in the study questionnaire survey\n\nPRIOR CONCURRENT THERAPY:\n\n* No limit on participation in the number of prior phase I trials or other studies'}, 'identificationModule': {'nctId': 'NCT00890435', 'briefTitle': 'Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Pharmacokinetic Participation Questionnaire Study', 'orgStudyIdInfo': {'id': 'ADVL08N1'}, 'secondaryIdInfos': [{'id': 'COG-ADVL08N1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-08-C-0223'}, {'id': 'CDR0000616064', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elizabeth Fox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}