Learning Impairments Among Survivors of Childhood Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00576472
First received: December 17, 2007
Last updated: February 27, 2014
Last verified: February 2013
Results First Received: October 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Acute Lymphoblastic Leukemia
Brain Tumors
Intervention: Drug: Methylphenidate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
505 patients were enrolled from 3 institutions between January, 2000 and February, 2009. 91 siblings were enrolled as a control group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 505 patients enrolled on the study, 36 were never assessed, and 469 participated in the initial screening. Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day MPH In-Lab Phase.

Reporting Groups
  Description
Mild Intensity Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
Moderate Intensity Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
High Intensity Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
Group M/P Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
Group P/M Group P/M (patients received oral placebo and then Methylphenidate (MPH))
Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
Placebo/Low Dose/Moderate Dose (PLM) The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Placebo/Moderate Dose/Low Dose (PML) The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
Low Dose/Moderate Dose/ Placebo (LMP) The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Low Dose/Placebo/Moderate Dose (LPM) The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Moderate Dose/Low Dose/Placebo (MLP) The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Moderate Dose/Placebo/Low Dose (MPL) The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
Declined Methylphenidate (MPH) Home Maintenance Phase Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
Methylphenidate (MPH) Home Maintenance Phase Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.

Participant Flow for 4 periods

Period 1:   Initial Screening
    Mild Intensity     Moderate Intensity     High Intensity     Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase     Group M/P     Group P/M     Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase     Placebo/Low Dose/Moderate Dose (PLM)     Placebo/Moderate Dose/Low Dose (PML)     Low Dose/Moderate Dose/ Placebo (LMP)     Low Dose/Placebo/Moderate Dose (LPM)     Moderate Dose/Low Dose/Placebo (MLP)     Moderate Dose/Placebo/Low Dose (MPL)     Declined Methylphenidate (MPH) Home Maintenance Phase     Methylphenidate (MPH) Home Maintenance Phase  
STARTED     230     40     199     0     0     0     0     0     0     0     0     0     0     0     0  
COMPLETED     230     40     199     0     0     0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0  

Period 2:   MPH In-Lab Phase
    Mild Intensity     Moderate Intensity     High Intensity     Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase     Group M/P     Group P/M     Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase     Placebo/Low Dose/Moderate Dose (PLM)     Placebo/Moderate Dose/Low Dose (PML)     Low Dose/Moderate Dose/ Placebo (LMP)     Low Dose/Placebo/Moderate Dose (LPM)     Moderate Dose/Low Dose/Placebo (MLP)     Moderate Dose/Placebo/Low Dose (MPL)     Declined Methylphenidate (MPH) Home Maintenance Phase     Methylphenidate (MPH) Home Maintenance Phase  
STARTED     0 [1]   0 [1]   0 [1]   335     67     67     0     0     0     0     0     0     0     0     0  
COMPLETED     0     0     0     0     67     67     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     335     0     0     0     0     0     0     0     0     0     0     0  
Declined participation in medication pha                 0                 0                 0                 75                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Patients did not qualify - IQ < 50                 0                 0                 0                 4                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
No attention/academic problems                 0                 0                 0                 245                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Psychiatric exclusion                 0                 0                 0                 10                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
[1] Group only associated with Screening phase.

Period 3:   MPH Cross Over Phase
    Mild Intensity     Moderate Intensity     High Intensity     Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase     Group M/P     Group P/M     Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase     Placebo/Low Dose/Moderate Dose (PLM)     Placebo/Moderate Dose/Low Dose (PML)     Low Dose/Moderate Dose/ Placebo (LMP)     Low Dose/Placebo/Moderate Dose (LPM)     Moderate Dose/Low Dose/Placebo (MLP)     Moderate Dose/Placebo/Low Dose (MPL)     Declined Methylphenidate (MPH) Home Maintenance Phase     Methylphenidate (MPH) Home Maintenance Phase  
STARTED     0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   12     20     18     22     23     18     21     0     0  
COMPLETED     0     0     0     0     0     0     0     20     16     22     22     17     21     0     0  
NOT COMPLETED     0     0     0     0     0     0     12     0     2     0     1     1     0     0     0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 6                 0                 0                 0                 0                 0                 0                 0                 0  
Ineligible due to disease                 0                 0                 0                 0                 0                 0                 2                 0                 0                 0                 0                 0                 0                 0                 0  
Physician Decision                 0                 0                 0                 0                 0                 0                 4                 0                 0                 0                 0                 0                 0                 0                 0  
Did not complete cross over phase                 0                 0                 0                 0                 0                 0                 0                 0                 2                 0                 1                 1                 0                 0                 0  
[1] Group not associated with MPH Cross-over phase.

Period 4:   MPH Home Maintenance Phase
    Mild Intensity     Moderate Intensity     High Intensity     Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase     Group M/P     Group P/M     Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase     Placebo/Low Dose/Moderate Dose (PLM)     Placebo/Moderate Dose/Low Dose (PML)     Low Dose/Moderate Dose/ Placebo (LMP)     Low Dose/Placebo/Moderate Dose (LPM)     Moderate Dose/Low Dose/Placebo (MLP)     Moderate Dose/Placebo/Low Dose (MPL)     Declined Methylphenidate (MPH) Home Maintenance Phase     Methylphenidate (MPH) Home Maintenance Phase  
STARTED     0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   27     91  
COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     0     68  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     27     23  
Did not meet response criteria                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 16                 0  
Declined to participate                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 7                 0  
Insufficient data                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 4                 0  
Side effects                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 8  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 6  
Medical reasons                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 6  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 3  
[1] Group not associated with Home Maintenance Phase.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mild Intensity of prior Central Nervous System radiation therapy was considered mild.
Moderate Intensity of prior Central Nervous System radiation therapy was considered moderate.
High Intensity of prior Central Nervous System radiation therapy was considered high.
Not Randomized-In Lab Phase Patients not randomized for the MPH in Lab Phase
Group M/P Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
Group P/M Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
Not Randomized-Cross Over Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
Placebo/Low Dose/Moderate Dose (PLM) The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Placebo/Moderate Dose/Low Dose (PML) The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
Low Dose/Moderate Dose/ Placebo (LMP) The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Low Dose/Placebo/Moderate Dose (LPM) The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Moderate Dose/Low Dose/Placebo (MLP) The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Moderate Dose/Placebo/Low Dose (MPL) The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
Declined Home Maintenance Phase Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
Home Maintenance Phase Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
Total Total of all reporting groups

Baseline Measures
    Mild     Moderate     High     Not Randomized-In Lab Phase     Group M/P     Group P/M     Not Randomized-Cross Over     Placebo/Low Dose/Moderate Dose (PLM)     Placebo/Moderate Dose/Low Dose (PML)     Low Dose/Moderate Dose/ Placebo (LMP)     Low Dose/Placebo/Moderate Dose (LPM)     Moderate Dose/Low Dose/Placebo (MLP)     Moderate Dose/Placebo/Low Dose (MPL)     Declined Home Maintenance Phase     Home Maintenance Phase     Total  
Number of Participants  
[units: participants]
  230     40     199     0     0     0     0     0     0     0     0     0     0     0     0     469  
Age, Customized  
[units: Participants]
                               
< 4 years of age     113     23     51                                                     187  
≥ 4 years of age     117     17     148                                                     282  
Gender  
[units: participants]
                               
Female     98     16     90                                                     204  
Male     132     24     109                                                     265  
Disease Group  
[units: Participants]
                               
Acute Lymphoblastic Leukemia (ALL)     216     39     3                                                     258  
Brain Tumors (BT)     14     1     196                                                     211  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brain White Matter Volume for Patients Versus Sibling Controls   [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

2.  Primary:   Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors   [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

3.  Primary:   Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls   [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

4.  Primary:   Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)   [ Time Frame: From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months. ]

5.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)   [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

6.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)   [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

7.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)   [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

8.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)   [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

9.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score   [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

10.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score   [ Time Frame: From beginning and after completion of home maintenance phase, on average 16.3 months. ]

11.  Primary:   Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score   [ Time Frame: From beginning and after completion of home maintenance phase, on average 16.3 months. ]

12.  Secondary:   Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.   [ Time Frame: weekly during 3-week home crossover phase ]

13.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

14.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Hyperactivity Scale.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

15.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) ADHD Index.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

16.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

17.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Hyperactivity Scale.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

18.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) ADHD Index.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks ]

19.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Social Skill.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

20.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Problem Behavior.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

21.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Social Skill.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

22.  Secondary:   Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Problem Behavior.   [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

23.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Omission Errors.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

24.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

25.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Hit Reaction Time.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

26.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d’ (Sensitivity).   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

27.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Beta (Risk Taking).   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

28.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

29.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

30.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

31.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

32.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

33.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

34.  Secondary:   Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.   [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]


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  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Heather Conklin PhD
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org


Publications:
Publications automatically indexed to this study:

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00576472     History of Changes
Other Study ID Numbers: MEMFX2, R01CA078957, U01CA081445, P30CA021765
Study First Received: December 17, 2007
Results First Received: October 28, 2011
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board