Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003788

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003788
  •   2012/05/04
  •   2005/11/22
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT00258453  (ClinicalTrials.gov)
  •   GPOH-CRANIOPHARYNGIOMA-2000  (Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany)
  •   EU-20537 
  •   CDR0000450768 
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Health Condition or Problem studied

  •   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
  •   D44 -  Neoplasm of uncertain or unknown behaviour of endocrine glands
  •   D44.4 -  Neoplasm of uncertain or unknown behaviour: Craniopharyngeal duct
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Interventions/Observational Groups

  •   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
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Characteristics

  •   Interventional
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  •   Open (masking not used)
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  •   Diagnostic
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  •   N/A
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   Austria
  •   Germany
  •   Sweden
  •   Switzerland
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Locations of Recruitment

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Recruitment

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  •   2001/05/31
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional 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

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Exclusion Criteria

[---]*

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Addresses

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    • Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
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    • Klinikum Oldenburg
    • Hermann Mueller, MD 
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    • Klinikum Oldenburg
    • Hermann Mueller, MD 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/09/01
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Trial Publications, Results and other Documents

  •   Clinical trial summary from the National Cancer Institute's PDQ® database
  •   Müller HL, Gebhardt U, Schröder S, Pohl F, Kortmann RD, Faldum A, Zwiener I, Warmuth-Metz M, Pietsch T, Calaminus G, Kolb R, Wiegand C, Sörensen N; study committee of KRANIOPHARYNGEOM 2000/2007. Analyses of treatment variables for patients with childhood craniopharyngioma--results of the multicenter prospective trial KRANIOPHARYNGEOM 2000 after three years of follow-up. Horm Res Paediatr. 2010;73(3):175-80. Epub 2010 Mar 3.; 20197669
  •   Roth CL, Gebhardt U, Müller HL. Appetite-regulating hormone changes in patients with craniopharyngioma. Obesity (Silver Spring). 2011 Jan;19(1):36-42. Epub 2010 Apr 8.; 20379145
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   65
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.