Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma
RATIONALE: Collecting information on how craniopharyngioma is diagnosed and treated may help doctors predict a patient's response to treatment and help plan the best treatment. It may also help identify the intermediate- and long-term effects of treatment.
PURPOSE: This clinical trial is collecting information on diagnosis, treatment, and quality of life of young patients who are undergoing surgery for craniopharyngioma.
|Brain and Central Nervous System Tumors Long-term Effects Secondary to Cancer Therapy in Children Perioperative/Postoperative Complications Psychosocial Effects of Cancer and Its Treatment Weight Changes||Other: metabolic assessment Other: physiologic testing Procedure: biopsy Procedure: computed tomography Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Radiation: radiation therapy|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma|
|Study Start Date:||May 2001|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
- Identify all applied therapy strategies in pediatric patients with craniopharyngioma.
- Correlate relapse status with different therapy strategies/modality in these patients.
- Determine the health status (i.e., ophthalmologic, neuropediatric, and endocrine findings) and the health-related quality of life of these patients after treatment.
- Determine the incidence of craniopharyngioma in pediatric patients.
- Identify quality control measures for diagnosis and therapy in these patients.
- Improve long-term care through a standardized follow-up program in these patients.
- Determine the efficacy of endocrine substitution for postoperative hypopituitarism in these patients.
- Identify risk factors for developing obesity and correlate the neurotransmitter concentration of leptin and neuropeptide Y in cerebral spinal fluid, serum, and craniopharyngioma cystic fluid with the likelihood of developing obesity in these patients.
- Determine the incidence and extent of eating disorders in these patients.
OUTLINE: This is a multicenter study.
Patients undergo neurologic, endocrine, and ophthalmologic tests and anthropometric diagnostic measurements. Patients then undergo 1 of the following surgical procedures: total resection; incomplete, subtotal, or partial resection; biopsy; or cyst pressure release. Patients whose tumor relapses may undergo a second resection and/or radiotherapy.
Quality of life is assessed at baseline and then periodically thereafter.
After surgery, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258453
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|Study Chair:||Hermann Mueller, MD||Klinikum Oldenburg|