Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma

Conditions
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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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis) Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch cysts or suprasellar cysts) are allowed but will undergo observation only PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: metabolic assessment|nan|
|Other: physiologic testing|nan|
|Procedure: biopsy|nan|
|Procedure: computed tomography|nan|
|Procedure: conventional surgery|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: management of therapy complications|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, long-term effects secondary to cancer therapy in children, perioperative/postoperative complications, weight changes, childhood craniopharyngioma