Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma
NCT ID: NCT00258453
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2001-05-31
2009-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
NONE
Interventions
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metabolic assessment
physiologic testing
biopsy
computed tomography
conventional surgery
magnetic resonance imaging
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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German Society for Pediatric Oncology and Hematology GPOH gGmbH
OTHER
Principal Investigators
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Hermann Mueller, MD
Role: STUDY_CHAIR
Klinikum Oldenburg
Locations
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Krankenhaus Dornbirn
Dornbirn, , Austria
Landeskrankenhaus Feldkirch
Feldkirch-Tisis, , Austria
Universitaet Kinderklinik
Graz, , Austria
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
LKH Leoben
Leoben, , Austria
A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
Linz, , Austria
Landes-Kinderkrankenhaus
Linz, , Austria
St. Johanns-Spital
Salzburg, , Austria
Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital
Schwarzach, , Austria
A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten
Steyr, , Austria
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, , Austria
St. Anna Children's Hospital
Vienna, , Austria
Kinderklinik - Universitaetsklinikum Aachen
Aachen, , Germany
Klinikum Augsburg
Augsburg, , Germany
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, , Germany
Klinikum am Bamberg
Bamberg, , Germany
Klinikum Bayreuth
Bayreuth, , Germany
Helios Klinikum Berlin
Berlin, , Germany
Charite - Campus Charite Mitte
Berlin, , Germany
Charite University Hospital - Campus Virchow Klinikum
Berlin, , Germany
Evangelisches Krankenhauus Bielfeld
Biefeld, , Germany
Kinderklinik der Universitaet Bonn
Bonn, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
Allgemeinen Krankenhaus Celle Kinderklinik
Celle, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Klinikum Coburg
Coburg, , Germany
Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl
Cologne, , Germany
Children's Hospital
Cologne, , Germany
Carl - Thiem - Klinkum Cottbus
Cottbus, , Germany
Vestische Kinderklinik Universitaetsklinik Witten/Herdecke
Datteln, , Germany
Klinikum Lippe - Detmold
Detmold, , Germany
Staedtisches Krankenhaus Dresden - Neustadt
Dresden, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Klinikum Duisburg
Duisburg, , Germany
Klinikum Erfurt
Erfurt, , Germany
Universitaets - Kinderklinik
Erlangen, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Kinderklinik
Giessen, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Universitats - Kinderklinik
Greiswald, , Germany
Kreiskrankenhaus Gummersbach GMBH
Gummersbach, , Germany
Universitaetsklinikum Halle
Halle, , Germany
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Kreskrankenhaus Kinderabteilung
Heide, , Germany
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, , Germany
Gemeinschaftskrankenhaus
Herdecke, , Germany
Staedtisches Krankenhaus Hildesheim
Hildesheim, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, , Germany
Universitaets - Kinderklinik
Jena, , Germany
Municipal Hospital Complex of the University
Kaiserslautern, , Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
Klinikum Kassel
Kassel, , Germany
Staedtisches Krankenhaus Kiel
Kiel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Klinikum Kemperhof Koblenz
Koblenz, , Germany
Klinik Konstanz
Konstanz, , Germany
Klinikum Krefeld GmbH
Krefeld, , Germany
Kinderkrankenhaus St. Marien
Landshut, , Germany
Universitaets - Kinderklinik
Leipzig, , Germany
St. Annastift Krankenhaus
Ludwigshafen, , Germany
Universitaets - Kinderklinik - Luebeck
Lübeck, , Germany
Universitatsklinikum der MA
Magdeburg, , Germany
Johannes Gutenberg University
Mainz, , Germany
Staedtisches Klinik - Kinderklinik
Mannheim, , Germany
Universitaets - Kinderklinik
Marburg, , Germany
Klinikum Minden
Minden, , Germany
Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
Mönchengladbach, , Germany
Krankenhaus Muenchen Schwabing
Munich, , Germany
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, , Germany
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, , Germany
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Neubrandenburg
Neubrandenburg, , Germany
Lukaskrankenhaus Neuss
Neuss, , Germany
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, , Germany
Cnopf'sche Kinderklinik
Nuremberg, , Germany
Klinikum Nuernberg - Klinikum Sued
Nuremberg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Marien Hospital
Osnabrück, , Germany
Paracelsus - Klinik Osnabrueck
Osnabrück, , Germany
Klinik St. Hedwig-Kinderklinik
Regensburg, , Germany
Kinderklinik - Universitaetsklinikum Rostock
Rostock, , Germany
Saarbrucker Winterbergkliniken
Saarbrücken, , Germany
Johanniter-Kinderklinik
Sankt Augustin, , Germany
Klinikum Schwerin
Schwerin, , Germany
Kinderklink Siegen Deutsches Rotes Kreuz
Siegen, , Germany
Olgahospital
Stuttgart, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
St. Marienhospital - Vechta
Vechta, , Germany
Staedtisches Klinikum - Howedestrase
Vechta, , Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , Germany
Reinhard-Nieter-Krankenhaus
Wilhelmshaven, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Helios Kliniken Wuppertal University Hospital
Wuppertal, , Germany
Universitaets - Kinderklinik Wuerzburg
Würzburg, , Germany
Lanssjukhuset Ryhov
Jönköping, , Sweden
Kantonspital Aarau
Aarau, , Switzerland
Universitaets-Kinderspital beider Basel
Basel, , Switzerland
Ospedale "la Carita", Locarno
Locarno, , Switzerland
Kinderspital Luzern
Lucerne, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
University Children's Hospital
Zurich, , Switzerland
Countries
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References
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Roth CL, Gebhardt U, Muller HL. Appetite-regulating hormone changes in patients with craniopharyngioma. Obesity (Silver Spring). 2011 Jan;19(1):36-42. doi: 10.1038/oby.2010.80. Epub 2010 Apr 8.
Muller HL, Gebhardt U, Schroder S, Pohl F, Kortmann RD, Faldum A, Zwiener I, Warmuth-Metz M, Pietsch T, Calaminus G, Kolb R, Wiegand C, Sorensen 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. doi: 10.1159/000284358. Epub 2010 Mar 3.
Sowithayasakul P, Beckhaus J, Ozyurt J, Bison B, Friedrich C, Muller HL. Prolactin serum concentrations in childhood-onset craniopharyngioma patients. J Endocrinol Invest. 2025 Sep;48(9):2041-2051. doi: 10.1007/s40618-025-02622-4. Epub 2025 Jun 7.
Mann-Markutzyk LV, Beckhaus J, Ozyurt J, Mehren A, Friedrich C, Muller HL. Daytime sleepiness and health-related quality of life in patients with childhood-onset craniopharyngioma. Sci Rep. 2025 Mar 19;15(1):9407. doi: 10.1038/s41598-025-94384-5.
Wagener K, Beckhaus J, Boekhoff S, Friedrich C, Muller HL. Sporadic and neurofibromatosis type 2-associated meningioma in children and adolescents. J Neurooncol. 2023 Jul;163(3):555-563. doi: 10.1007/s11060-023-04344-0. Epub 2023 Jul 4.
Beckhaus J, Friedrich C, Boekhoff S, Calaminus G, Bison B, Eveslage M, Timmermann B, Flitsch J, Muller HL. Outcome after pediatric craniopharyngioma: the role of age at diagnosis and hypothalamic damage. Eur J Endocrinol. 2023 Mar 2;188(3):lvad027. doi: 10.1093/ejendo/lvad027.
Mehren A, Ozyurt J, Zu Klampen P, Boekhoff S, Thiel CM, Muller HL. Self- and informant-rated apathy in patients with childhood-onset craniopharyngioma. J Neurooncol. 2018 Oct;140(1):27-35. doi: 10.1007/s11060-018-2936-z. Epub 2018 Jul 3.
Ozyurt J, Muller HL, Warmuth-Metz M, Thiel CM. Hypothalamic tumors impact gray and white matter volumes in fronto-limbic brain areas. Cortex. 2017 Apr;89:98-110. doi: 10.1016/j.cortex.2017.01.017. Epub 2017 Feb 3.
Daubenbuchel AM, Hoffmann A, Eveslage M, Ozyurt J, Lohle K, Reichel J, Thiel CM, Martens H, Geenen V, Muller HL. Oxytocin in survivors of childhood-onset craniopharyngioma. Endocrine. 2016 Nov;54(2):524-531. doi: 10.1007/s12020-016-1084-5. Epub 2016 Sep 1.
Hoffmann A, Warmuth-Metz M, Lohle K, Reichel J, Daubenbuchel AM, Sterkenburg AS, Muller HL. Fusiform dilatation of the internal carotid artery in childhood-onset craniopharyngioma: multicenter study on incidence and long-term outcome. Pituitary. 2016 Aug;19(4):422-8. doi: 10.1007/s11102-016-0722-5.
Ozyurt J, Thiel CM, Lorenzen A, Gebhardt U, Calaminus G, Warmuth-Metz M, Muller HL. Neuropsychological outcome in patients with childhood craniopharyngioma and hypothalamic involvement. J Pediatr. 2014 Apr;164(4):876-881.e4. doi: 10.1016/j.jpeds.2013.12.010. Epub 2014 Feb 6.
Roth CL, Enriori PJ, Gebhardt U, Hinney A, Muller HL, Hebebrand J, Reinehr T, Cowley MA. Changes of peripheral alpha-melanocyte-stimulating hormone in childhood obesity. Metabolism. 2010 Feb;59(2):186-94. doi: 10.1016/j.metabol.2009.06.031. Epub 2009 Sep 18.
Other Identifiers
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CDR0000450768
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20537
Identifier Type: -
Identifier Source: secondary_id
GPOH-CRANIOPHARYNGIOMA-2000
Identifier Type: -
Identifier Source: org_study_id