Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258453
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2005-11-22
Brief Title:
Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma
Sponsor:
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Prospective Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Collecting information on how craniopharyngioma is diagnosed and treated may help doctors predict a patients 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
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 strategiesmodality in these patients
Determine the health status ie 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 andor 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
Primary
Identify all applied therapy strategies in pediatric patients with craniopharyngioma
Correlate relapse status with different therapy strategiesmodality in these patients
Determine the health status ie 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 andor 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20537 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000450768 | REGISTRY | None | None |