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Brain and Central Nervous System TumorsNCT00258453

Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

A study testing metabolic assessment, physiologic testing and biopsy in people with Brain and Central Nervous System Tumors and Long-term Effects Secondary to Cancer Therapy in Children, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 109 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
What is being tested?
metabolic assessment, physiologic testing and biopsy
Type of treatment
Surgery or procedure
How many people
120 participants
Where
109 sitesin 4 countries
Study dates
May 2001to Sep 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

109 sites in 4 countries.

109 sites in 4 countries

Germany88 sites

  • Kinderklinik - Universitaetsklinikum Aachen

    Aachen, D-52074

  • Klinikum Augsburg

    Augsburg, D-86156

  • Caritas-Krankenhaus Bad Mergentheim

    Bad Mergentheim, D-97980

  • Klinikum am Bamberg

    Bamberg, 96049

  • Klinikum Bayreuth

    Bayreuth, D-95445

  • Helios Klinikum Berlin

    Berlin, 13125

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Evangelisches Krankenhauus Bielfeld

    Biefeld, 33617

  • Kinderklinik der Universitaet Bonn

    Bonn, D-53113

  • Klinikum Bremen-Mitte

    Bremen, D-28205

  • Allgemeinen Krankenhaus Celle Kinderklinik

    Celle, 29223

  • Klinikum Chemnitz gGmbH

    Chemnitz, D-09116

  • Klinikum Coburg

    Coburg, 96450

  • Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

    Cologne, D-50735

  • Children's Hospital

    Cologne, D-50924

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

  • Vestische Kinderklinik Universitaetsklinik Witten/Herdecke

    Datteln, 45711

  • Klinikum Lippe - Detmold

    Detmold, D-32756

  • Staedtisches Krankenhaus Dresden - Neustadt

    Dresden, D-01129

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Klinikum Duisburg

    Duisburg, D-47055

  • Klinikum Erfurt

    Erfurt, 99089

  • Universitaets - Kinderklinik

    Erlangen, D-91054

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Universitaetskinderklinik - Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • Kinderklinik

    Giessen, D-35385

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Universitats - Kinderklinik

    Greiswald, 17487

  • Kreiskrankenhaus Gummersbach GMBH

    Gummersbach, D-51643

  • Universitaetsklinikum Halle

    Halle, D-06097

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Kreskrankenhaus Kinderabteilung

    Heide, 25746

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

  • SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

    Heilbronn, D-74064

  • Gemeinschaftskrankenhaus

    Herdecke, 58313

  • Staedtisches Krankenhaus Hildesheim

    Hildesheim, D-31134

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Universitaets - Kinderklinik

    Jena, D-07745

  • Municipal Hospital Complex of the University

    Kaiserslautern, 67655

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Klinikum Kassel

    Kassel, D-34125

  • Staedtisches Krankenhaus Kiel

    Kiel, 23116

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Klinikum Kemperhof Koblenz

    Koblenz, D-56065

  • Klinik Konstanz

    Konstanz, 78461

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

  • Kinderkrankenhaus St. Marien

    Landshut, 84036

  • Universitaets - Kinderklinik

    Leipzig, D-04317

  • Universitaets - Kinderklinik - Luebeck

    Lübeck, D-23538

  • St. Annastift Krankenhaus

    Ludwigshafen, 67065

  • Universitatsklinikum der MA

    Magdeburg, 39112

  • Johannes Gutenberg University

    Mainz, D-55131

  • Staedtisches Klinik - Kinderklinik

    Mannheim, D-68167

  • Universitaets - Kinderklinik

    Marburg, 35033

  • Klinikum Minden

    Minden, D-32423

  • Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin

    Mönchengladbach, D-41066

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Dr. von Haunersches Kinderspital der Universitaet Muenchen

    Munich, D-80337

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

    Münster, D-48149

  • Klinikum Neubrandenburg

    Neubrandenburg, 17036

  • Lukaskrankenhaus Neuss

    Neuss, D-41464

  • Marienhaus Klinikum St. Elisabeth Neuwied

    Neuwied, 56564

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

  • Klinikum Nuernberg - Klinikum Sued

    Nuremberg, D-90471

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Marien Hospital

    Osnabrück, D-49074

  • Paracelsus - Klinik Osnabrueck

    Osnabrück, D-49076

  • Klinik St. Hedwig-Kinderklinik

    Regensburg, 93049

  • Kinderklinik - Universitaetsklinikum Rostock

    Rostock, D-18057

  • Saarbrucker Winterbergkliniken

    Saarbrücken, 66119

  • Johanniter-Kinderklinik

    Sankt Augustin, 53757

  • Klinikum Schwerin

    Schwerin, D-19049

  • Kinderklink Siegen Deutsches Rotes Kreuz

    Siegen, D-57072

  • Olgahospital

    Stuttgart, D-70176

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89075

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Staedtisches Klinikum - Howedestrase

    Vechta, D-49377

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

  • Reinhard-Nieter-Krankenhaus

    Wilhelmshaven, D-26389

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, D-38440

  • Helios Kliniken Wuppertal University Hospital

    Wuppertal, D-42283

  • Universitaets - Kinderklinik Wuerzburg

    Würzburg, D-97080

Other trials in Germany

Austria13 sites

  • Krankenhaus Dornbirn

    Dornbirn, A-6850

  • Landeskrankenhaus Feldkirch

    Feldkirch-Tisis, A-6807

  • Universitaet Kinderklinik

    Graz, 8036

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, 9026

  • LKH Leoben

    Leoben, A-8700

  • A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

    Linz, 4010

  • Landes-Kinderkrankenhaus

    Linz, A-4020

  • St. Johanns-Spital

    Salzburg, A-5020

  • Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital

    Schwarzach, 5620

  • A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten

    Steyr, 4400

  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Vienna, 1090

  • St. Anna Children's Hospital

    Vienna, A-1090

Other trials in Austria

Switzerland7 sites

  • Kantonspital Aarau

    Aarau, CH-5001

  • Universitaets-Kinderspital beider Basel

    Basel, CH-4005

  • Ospedale "la Carita", Locarno

    Locarno, 6600

  • Kinderspital Luzern

    Lucerne, CH-6000

  • Ostschweizer Kinderspital

    Sankt Gallen, 9006

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • University Children's Hospital

    Zurich, CH-8032

Other trials in Switzerland

Sweden1 site

  • Lanssjukhuset Ryhov

    Jönköping, S-55185

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
metabolic assessment, physiologic testing, biopsy, computed tomography, conventional surgery
Keywords
psychosocial effects of cancer and its treatment, long-term effects secondary to cancer therapy in children, perioperative/postoperative complications, weight changes, childhood craniopharyngioma
Medical subject headings
Central Nervous System Neoplasms, Postoperative Complications, Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metabolic assessmentOther

  • physiologic testingOther

  • biopsyProcedure or surgery

  • computed tomographyProcedure or surgery

  • conventional surgeryProcedure or surgery

  • magnetic resonance imagingProcedure or surgery

  • management of therapy complicationsProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2005 (estimated)
  2. Study startMay 2001
  3. Primary completionSep 2007
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00258453
Sponsor's protocol ID
GPOH-CRANIOPHARYNGIOMA-2000
Other IDs
CDR0000450768, EU-20537
Status last verified
Oct 2007
First submitted
22 Nov 2005
Last updated
2 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 20379145

  • 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.

    PubMed 20197669

  • 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.

    PubMed 40481916

  • 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.

    PubMed 40108339

  • 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.

    PubMed 37402092

  • 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.

    PubMed 36857103

  • 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.

    PubMed 29971569

  • 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.

    PubMed 28259055

  • 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.

    PubMed 27585663

  • 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.

    PubMed 27125511

  • 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.

    PubMed 24507865

  • 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.

    PubMed 19766264

Questions about this trial

What is this clinical trial studying?

A study testing metabolic assessment, physiologic testing and biopsy in people with Brain and Central Nervous System Tumors and Long-term Effects Secondary to Cancer Therapy in Children, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 109 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Germany, Austria, Switzerland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00258453, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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