- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890435
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
A Pharmacokinetic Participation Questionnaire Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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Must not have withdrawn consent for the phase I treatment study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
- Must not withdraw consent for PK sampling prior to completing the study questionnaire if initially agreed to optional 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:
- Not cognitively or physically impaired
- May participate no more than once in the study questionnaire survey
PRIOR CONCURRENT THERAPY:
- No limit on participation in the number of prior phase I trials or other studies
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between study questionnaire answers and patient demographics
Time Frame: Length of study
|
Length of study
|
Correlation between study questionnaire answers and time required by pharmacokinetic sampling
Time Frame: Length of study
|
Length of study
|
Correlation between study questionnaire answers and the need for additional IV
Time Frame: Length of study
|
Length of study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Fox, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- unspecified adult solid tumor, protocol specific
- recurrent adult brain tumor
- chronic myelomonocytic 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
- juvenile myelomonocytic leukemia
- childhood chronic myelogenous leukemia
- recurrent adult acute myeloid leukemia
- adult brain stem glioma
- adult choroid plexus tumor
- adult craniopharyngioma
- adult ependymoblastoma
- adult medulloblastoma
- adult supratentorial primitive neuroectodermal tumor (PNET)
- adult mixed glioma
- relapsing chronic myelogenous leukemia
- refractory chronic lymphocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- recurrent childhood acute lymphoblastic leukemia
- childhood medulloepithelioma
- recurrent childhood acute myeloid leukemia
- adult astrocytic tumors
- adult pineal parenchymal tumor
- acute undifferentiated leukemia
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- childhood oligodendroglioma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- recurrent childhood brain stem glioma
- recurrent childhood medulloblastoma
- recurrent childhood visual pathway and hypothalamic glioma
- childhood craniopharyngioma
- childhood choroid plexus tumor
- mast cell leukemia
- T-cell large granular lymphocyte leukemia
- recurrent childhood pineoblastoma
- childhood ependymoblastoma
- recurrent childhood subependymal giant cell astrocytoma
- childhood meningioma
- childhood mixed glioma
- adult ependymal tumors
- adult meningeal tumor
- adult oligodendroglial tumors
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADVL08N1
- COG-ADVL08N1 (Other Identifier: Children's Oncology Group)
- NCI-08-C-0223
- CDR0000616064 (Other Identifier: Clinical Trials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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