An observational study in Long-term Effects Secondary to Cancer Therapy in Children and Neurotoxicity, sponsored by Children's Oncology Group. Completed at 26 sites in 2 countries. Open to participants aged 1 Year to 9 Years. Per ClinicalTrials.gov, last updated 2014-02-13.
Sponsored by Children's Oncology Group · Observational
RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.
PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.
OBJECTIVES:
OUTLINE: This is a multicenter study.
More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.
PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.
137 studies on the registry are indexed under Neurotoxicity Syndromes; 16 are open to participants now.
This study's enrollment of 66 is below the median of 86 across 38 observational studies indexed under Neurotoxicity Syndromes.
Browse Neurotoxicity Syndromes studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Previously enrolled on POG-9201 or POG-9605
DISEASE CHARACTERISTICS:
Previously enrolled on POG-9201 or POG-9605
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Percentage of patients with severe intelligence deficit as evidenced by either a verbal or performance IQ below 85
Time frame: Length of study
Compare the groups for descriptive purposes
Quantitative scales: IQ (WISC III or WPPSI-R, depending on the age of the child), Wide Range Assessment of Memory and Learning (4 subscales), Conner's Continuous Performance Test (Attention/Concentration), Woodcock Johnson Revised Processing Speed Cluster, NEPSP Tower Tests (Executive Functioning), and VSI (Visual-Motor Integration).
Time frame: Length of study
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Oncology Group