NCT00258453

Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• 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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-05-01
• Primary completion: 2007-09-01
• Completion: 2009-09-01
• First posted: 2005-11-24
• Last updated: 2013-08-02

Locations

109 sites across 4 countries: Austria, Germany, Sweden, Switzerland