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| ID | Type | Description | Link |
|---|---|---|---|
| COG-ADVL08N1 | Other Identifier | Children's Oncology Group | |
| NCI-08-C-0223 | |||
| CDR0000616064 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients 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.
Patient demographics and other relevant information are collected.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | |||
| psychosocial assessment and care | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between study questionnaire answers and patient demographics | Length of study | |
| Correlation between study questionnaire answers and time required by pharmacokinetic sampling | Length of study | |
| Correlation between study questionnaire answers and the need for additional IV | Length of study |
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DISEASE CHARACTERISTICS:
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
Must not have withdrawn consent for the phase I treatment study
Patients or their parents/guardians are eligible regardless of whether they initially agreed to participate in the PK sampling
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)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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A patient (family) who has consented to participate in a Phase I trial.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Fox, MD | National Cancer Institute (NCI) | Principal Investigator |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007938 | Leukemia |
| D001254 | Astrocytoma |
| D008527 | Medulloblastoma |
| C531673 | Familial ependymoma |
| D020339 | Optic Nerve Glioma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016545 | Choroid Plexus Neoplasms |
| D008579 | Meningioma |
| D009837 | Oligodendroglioma |
| D003397 | Craniopharyngioma |
| D018242 | Neuroectodermal Tumors, Primitive |
| D008577 | Meningeal Neoplasms |
| D005910 | Glioma |
| D010871 | Pinealoma |
| D001932 | Brain Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D015456 | Leukemia, Biphenotypic, Acute |
| D007946 | Leukemia, Mast-Cell |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D007943 | Leukemia, Hairy Cell |
| D015463 | Leukemia, Prolymphocytic |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002551 | Cerebral Ventricle Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D034721 | Mastocytosis, Systemic |
| D008415 | Mastocytosis |
| D000090362 | Mast Cell Activation Disorders |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
| D015448 | Leukemia, B-Cell |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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