NCT00258453

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
4 countries

109 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

October 1, 2007

Enrollment Period

6.3 years

First QC Date

November 22, 2005

Last Update Submit

August 1, 2013

Conditions

Keywords

psychosocial effects of cancer and its treatmentlong-term effects secondary to cancer therapy in childrenperioperative/postoperative complicationsweight changeschildhood craniopharyngioma

Interventions

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (109)

Krankenhaus Dornbirn

Dornbirn, A-6850, Austria

Location

Landeskrankenhaus Feldkirch

Feldkirch-Tisis, A-6807, Austria

Location

Universitaet Kinderklinik

Graz, 8036, Austria

Location

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Landeskrankenhaus Klagenfurt

Klagenfurt, 9026, Austria

Location

LKH Leoben

Leoben, A-8700, Austria

Location

A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

Linz, 4010, Austria

Location

Landes-Kinderkrankenhaus

Linz, A-4020, Austria

Location

St. Johanns-Spital

Salzburg, A-5020, Austria

Location

Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital

Schwarzach, 5620, Austria

Location

A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten

Steyr, 4400, Austria

Location

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

Vienna, 1090, Austria

Location

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Klinikum Augsburg

Augsburg, D-86156, Germany

Location

Caritas-Krankenhaus Bad Mergentheim

Bad Mergentheim, D-97980, Germany

Location

Klinikum am Bamberg

Bamberg, 96049, Germany

Location

Klinikum Bayreuth

Bayreuth, D-95445, Germany

Location

Helios Klinikum Berlin

Berlin, 13125, Germany

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Evangelisches Krankenhauus Bielfeld

Biefeld, 33617, Germany

Location

Kinderklinik der Universitaet Bonn

Bonn, D-53113, Germany

Location

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

Location

Allgemeinen Krankenhaus Celle Kinderklinik

Celle, 29223, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, D-09116, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

Cologne, D-50735, Germany

Location

Children's Hospital

Cologne, D-50924, Germany

Location

Carl - Thiem - Klinkum Cottbus

Cottbus, D-03048, Germany

Location

Vestische Kinderklinik Universitaetsklinik Witten/Herdecke

Datteln, 45711, Germany

Location

Klinikum Lippe - Detmold

Detmold, D-32756, Germany

Location

Staedtisches Krankenhaus Dresden - Neustadt

Dresden, D-01129, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Klinikum Duisburg

Duisburg, D-47055, Germany

Location

Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universitaets - Kinderklinik

Erlangen, D-91054, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Kinderklinik

Giessen, D-35385, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Universitats - Kinderklinik

Greiswald, 17487, Germany

Location

Kreiskrankenhaus Gummersbach GMBH

Gummersbach, D-51643, Germany

Location

Universitaetsklinikum Halle

Halle, D-06097, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Kreskrankenhaus Kinderabteilung

Heide, 25746, Germany

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

Heilbronn, D-74064, Germany

Location

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

Location

Staedtisches Krankenhaus Hildesheim

Hildesheim, D-31134, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Universitaets - Kinderklinik

Jena, D-07745, Germany

Location

Municipal Hospital Complex of the University

Kaiserslautern, 67655, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

Staedtisches Krankenhaus Kiel

Kiel, 23116, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Klinikum Kemperhof Koblenz

Koblenz, D-56065, Germany

Location

Klinik Konstanz

Konstanz, 78461, Germany

Location

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

Location

Kinderkrankenhaus St. Marien

Landshut, 84036, Germany

Location

Universitaets - Kinderklinik

Leipzig, D-04317, Germany

Location

St. Annastift Krankenhaus

Ludwigshafen, 67065, Germany

Location

Universitaets - Kinderklinik - Luebeck

Lübeck, D-23538, Germany

Location

Universitatsklinikum der MA

Magdeburg, 39112, Germany

Location

Johannes Gutenberg University

Mainz, D-55131, Germany

Location

Staedtisches Klinik - Kinderklinik

Mannheim, D-68167, Germany

Location

Universitaets - Kinderklinik

Marburg, 35033, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin

Mönchengladbach, D-41066, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

Location

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, D-80337, Germany

Location

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

Location

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Klinikum Neubrandenburg

Neubrandenburg, 17036, Germany

Location

Lukaskrankenhaus Neuss

Neuss, D-41464, Germany

Location

Marienhaus Klinikum St. Elisabeth Neuwied

Neuwied, 56564, Germany

Location

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinikum Nuernberg - Klinikum Sued

Nuremberg, D-90471, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Marien Hospital

Osnabrück, D-49074, Germany

Location

Paracelsus - Klinik Osnabrueck

Osnabrück, D-49076, Germany

Location

Klinik St. Hedwig-Kinderklinik

Regensburg, 93049, Germany

Location

Kinderklinik - Universitaetsklinikum Rostock

Rostock, D-18057, Germany

Location

Saarbrucker Winterbergkliniken

Saarbrücken, 66119, Germany

Location

Johanniter-Kinderklinik

Sankt Augustin, 53757, Germany

Location

Klinikum Schwerin

Schwerin, D-19049, Germany

Location

Kinderklink Siegen Deutsches Rotes Kreuz

Siegen, D-57072, Germany

Location

Olgahospital

Stuttgart, D-70176, Germany

Location

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54290, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89075, Germany

Location

St. Marienhospital - Vechta

Vechta, D-49377, Germany

Location

Staedtisches Klinikum - Howedestrase

Vechta, D-49377, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Reinhard-Nieter-Krankenhaus

Wilhelmshaven, D-26389, Germany

Location

Klinikum der Stadt Wolfsburg

Wolfsburg, D-38440, Germany

Location

Helios Kliniken Wuppertal University Hospital

Wuppertal, D-42283, Germany

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Lanssjukhuset Ryhov

Jönköping, S-55185, Sweden

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Universitaets-Kinderspital beider Basel

Basel, CH-4005, Switzerland

Location

Ospedale "la Carita", Locarno

Locarno, 6600, Switzerland

Location

Kinderspital Luzern

Lucerne, CH-6000, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

Related Publications (12)

  • 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.

MeSH Terms

Conditions

Central Nervous System NeoplasmsPostoperative ComplicationsBody Weight Changes

Interventions

BiopsyMagnetic Resonance SpectroscopyPsychiatric RehabilitationRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hermann Mueller, MD

    Klinikum Oldenburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

May 1, 2001

Primary Completion

September 1, 2007

Study Completion

September 1, 2009

Last Updated

August 2, 2013

Record last verified: 2007-10

Locations