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Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00258453
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
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 Other: metabolic assessment Other: physiologic testing Procedure: 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 Radiation: radiation therapy Not Applicable

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma
Study Start Date : May 2001
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00258453

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Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
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Study Chair: Hermann Mueller, MD Klinikum Oldenburg

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00258453    
CDR0000450768 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: October 2007
Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
long-term effects secondary to cancer therapy in children
perioperative/postoperative complications
weight changes
childhood craniopharyngioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Postoperative Complications
Body Weight Changes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Body Weight
Signs and Symptoms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases