Skip to content

Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258453
Enrollment
120
Registered
2005-11-24
Start date
2001-05-31
Completion date
2009-09-30
Last updated
2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

psychosocial effects of cancer and its treatment, long-term effects secondary to cancer therapy in children, perioperative/postoperative complications, weight changes, childhood craniopharyngioma

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.

Interventions

OTHERphysiologic testing
PROCEDUREbiopsy
PROCEDUREcomputed tomography
PROCEDUREconventional surgery
PROCEDUREmagnetic resonance imaging
PROCEDUREmanagement of therapy complications
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
RADIATIONradiation therapy

Sponsors

German Society for Pediatric Oncology and Hematology GPOH gGmbH
Lead SponsorOTHER

Study design

Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

Austria, Germany, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026