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Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

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ClinicalTrials.gov Identifier: NCT00258453
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : August 2, 2013
Sponsor:
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:

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 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

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


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 ClinicalTrials.gov identifier (NCT number): NCT00258453


  Show 109 Study Locations
Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
Study Chair: Hermann Mueller, MD Klinikum Oldenburg

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00258453     History of Changes
Other Study ID Numbers: GPOH-CRANIOPHARYNGIOMA-2000
CDR0000450768 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20537
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:
Postoperative Complications
Nervous System Neoplasms
Central Nervous System Neoplasms
Body Weight Changes
Craniopharyngioma
Adamantinoma
Pathologic Processes
Neoplasms by Site
Neoplasms
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