Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Brain and Central Nervous System Tumors Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Weight Changes
• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Craniopharyngioma
• Long-term Effects Secondary to Cancer Therapy in Children
• Nervous System Neoplasms
• Perioperative/Postoperative Complications
• Postoperative Complications
• Psychosocial Effects of Cancer and Its Treatment
• Weight Changes

• NCT number: NCT00258453
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: N/A
• Start date: May 2001
• Completion date: September 2009