Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Not Applicable

Completed

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

• Registration Number: NCT00258453
• Lead Sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH

Brief 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.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-24
• Primary Completion: 2007-09
• Status Verified: 2007-10
• Study Completion: 2009-09
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (106)

Krankenhaus Dornbirn; 🇦🇹 Dornbirn, Austria

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch-Tisis, Austria

Universitaet Kinderklinik; 🇦🇹 Graz, Austria

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Landeskrankenhaus Klagenfurt; 🇦🇹 Klagenfurt, Austria

LKH Leoben; 🇦🇹 Leoben, Austria

A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung; 🇦🇹 Linz, Austria

Landes-Kinderkrankenhaus; 🇦🇹 Linz, Austria

St. Johanns-Spital; 🇦🇹 Salzburg, Austria

Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital; 🇦🇹 Schwarzach, Austria

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