Skip to main content
OpenTrials
Completed

NCT Number: NCT00258453

Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain and Central Nervous System Tumors Body Weight Body Weight Changes Central Nervous System Neoplasms Long-term Effects Secondary to Cancer Therapy in Children Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Psychosocial Effects of Cancer and Its Treatment Signs and Symptoms Weight Changes

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Dornbirn, Dornbirn, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metabolic assessment

Other

Physiologic Testing

Other

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

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2007
Study completion
2009
First posted
Nov 24, 2005
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.