Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma
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|ClinicalTrials.gov Identifier: NCT00258453|
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258453
|Study Chair:||Hermann Mueller, MD||Klinikum Oldenburg|