Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

August 1, 2013 updated by: Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Dornbirn, Austria, A-6850
    - Krankenhaus Dornbirn
  - Feldkirch-Tisis, Austria, A-6807
    - Landeskrankenhaus Feldkirch
  - Graz, Austria, 8036
    - Universitaet Kinderklinik
  - Innsbruck, Austria, A-6020
    - Innsbruck Universitaetsklinik
  - Klagenfurt, Austria, 9026
    - Landeskrankenhaus Klagenfurt
  - Leoben, Austria, A-8700
    - LKH Leoben
  - Linz, Austria, 4010
    - A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
  - Linz, Austria, A-4020
    - Landes-Kinderkrankenhaus
  - Salzburg, Austria, A-5020
    - St. Johanns-Spital
  - Schwarzach, Austria, 5620
    - Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital
  - Steyr, Austria, 4400
    - A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten
  - Vienna, Austria, A-1090
    - St. Anna Children's Hospital
  - Wien, Austria, 1090
    - Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Germany
- - Aachen, Germany, D-52074
    - Kinderklinik - Universitaetsklinikum Aachen
  - Augsburg, Germany, D-86156
    - Klinikum Augsburg
  - Bad Mergentheim, Germany, D-97980
    - Caritas-Krankenhaus Bad Mergentheim
  - Bamberg, Germany, 96049
    - Klinikum am Bamberg
  - Bayreuth, Germany, D-95445
    - Klinikum Bayreuth
  - Berlin, Germany, D-13353
    - Charite University Hospital - Campus Virchow Klinikum
  - Berlin, Germany, D-10117
    - Charité - Campus Charité Mitte
  - Berlin, Germany, 13125
    - Helios Klinikum Berlin
  - Biefeld, Germany, 33617
    - Evangelisches Krankenhauus Bielfeld
  - Bonn, Germany, D-53113
    - Kinderklinik der Universitaet Bonn
  - Bremen, Germany, D-28205
    - Klinikum Bremen-Mitte
  - Celle, Germany, 29223
    - Allgemeinen Krankenhaus Celle Kinderklinik
  - Chemnitz, Germany, D-09116
    - Klinikum Chemnitz gGmbH
  - Coburg, Germany, 96450
    - Klinikum Coburg
  - Cologne, Germany, D-50924
    - Children's Hospital
  - Cologne, Germany, D-50735
    - Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl
  - Cottbus, Germany, D-03048
    - Carl - Thiem - Klinkum Cottbus
  - Datteln, Germany, 45711
    - Vestische Kinderklinik Universitaetsklinik Witten/Herdecke
  - Detmold, Germany, D-32756
    - Klinikum Lippe - Detmold
  - Dresden, Germany, D-01307
    - Universitatsklinikum Carl Gustav Carus
  - Dresden, Germany, D-01129
    - Staedtisches Krankenhaus Dresden - Neustadt
  - Duisburg, Germany, D-47055
    - Klinikum Duisburg
  - Erfurt, Germany, 99089
    - Klinikum Erfurt
  - Erlangen, Germany, D-91054
    - Universitaets - Kinderklinik
  - Frankfurt, Germany, D-60590
    - Klinikum der J.W. Goethe Universitaet
  - Freiburg, Germany, D-79106
    - Universitaetskinderklinik - Universitaetsklinikum Freiburg
  - Giessen, Germany, D-35385
    - Kinderklinik
  - Goettingen, Germany, D-37075
    - Universitaetsklinikum Goettingen
  - Greiswald, Germany, 17487
    - Universitats - Kinderklinik
  - Gummersbach, Germany, D-51643
    - Kreiskrankenhaus Gummersbach GmbH
  - Halle, Germany, D-06097
    - Universitaetsklinikum Halle
  - Hamburg, Germany, D-20246
    - University Medical Center Hamburg - Eppendorf
  - Hannover, Germany, D-30625
    - Medizinische Hochschule Hannover
  - Heide, Germany, 25746
    - Kreskrankenhaus Kinderabteilung
  - Heidelberg, Germany, D-69120
    - Universitaets-Kinderklinik Heidelberg
  - Heilbronn, Germany, D-74064
    - SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
  - Herdecke, Germany, 58313
    - Gemeinschaftskrankenhaus
  - Hildesheim, Germany, D-31134
    - Staedtisches Krankenhaus Hildesheim
  - Homburg, Germany, 66421
    - Universitaetsklinikum des Saarlandes
  - Idar-Oberstein, Germany, D-55743
    - Clinic for Bone Marrow Transplantation and Hematology and Oncology
  - Jena, Germany, D-07745
    - Universitaets - Kinderklinik
  - Kaiserslautern, Germany, 67655
    - Municipal Hospital Complex of the University
  - Karlsruhe, Germany, 76133
    - Staedtisches Klinikum Karlsruhe gGmbH
  - Kassel, Germany, D-34125
    - Klinikum Kassel
  - Kiel, Germany, D-24105
    - University Hospital Schleswig-Holstein - Kiel Campus
  - Kiel, Germany, 23116
    - Staedtisches Krankenhaus Kiel
  - Koblenz, Germany, D-56065
    - Klinikum Kemperhof Koblenz
  - Konstanz, Germany, 78461
    - Klinik Konstanz
  - Krefeld, Germany, D-47805
    - Klinikum Krefeld GmbH
  - Landshut, Germany, 84036
    - Kinderkrankenhaus St. Marien
  - Leipzig, Germany, D-04317
    - Universitaets - Kinderklinik
  - Ludwigshafen, Germany, 67065
    - St. Annastift Krankenhaus
  - Luebeck, Germany, D-23538
    - Universitaets - Kinderklinik - Luebeck
  - Magdeburg, Germany, 39112
    - Universitatsklinikum der MA
  - Mainz, Germany, D-55131
    - Johannes Gutenberg University
  - Mannheim, Germany, D-68167
    - Staedtisches Klinik - Kinderklinik
  - Marburg, Germany, 35033
    - Universitaets - Kinderklinik
  - Minden, Germany, D-32423
    - Klinikum Minden
  - Moenchengladbach, Germany, D-41066
    - Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
  - Muenster, Germany, D-48149
    - Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
  - Munich, Germany, 80804
    - Krankenhaus Muenchen Schwabing
  - Munich, Germany, D-80337
    - Dr. von Haunersches Kinderspital der Universitaet Muenchen
  - Munich, Germany, D-81545
    - Staedtisches Krankenhaus Muenchen - Harlaching
  - Neubrandenburg, Germany, 17036
    - Klinikum Neubrandenburg
  - Neuss, Germany, D-41464
    - Lukaskrankenhaus Neuss
  - Neuwied, Germany, 56564
    - Marienhaus Klinikum St. Elisabeth Neuwied
  - Nuremberg, Germany, 90419
    - Cnopf'sche Kinderklinik
  - Nuremberg, Germany, D-90471
    - Klinikum Nuernberg - Klinikum Sued
  - Oldenburg, Germany, 26133
    - Klinikum Oldenburg
  - Osnabruck, Germany, D-49074
    - Marien Hospital
  - Osnabrueck, Germany, D-49076
    - Paracelsus - Klinik Osnabrueck
  - Regensburg, Germany, 93049
    - Klinik St. Hedwig-Kinderklinik
  - Rostock, Germany, D-18057
    - Kinderklinik - Universitaetsklinikum Rostock
  - Saarbrucken, Germany, 66119
    - Saarbrucker Winterbergkliniken
  - Schwerin, Germany, D-19049
    - Klinikum Schwerin
  - Siegen, Germany, D-57072
    - Kinderklink Siegen Deutsches Rotes Kreuz
  - St. Augustin, Germany, 53757
    - Johanniter-Kinderklinik
  - Stuttgart, Germany, D-70176
    - Olgahospital
  - Trier, Germany, D-54290
    - Krankenanstalt Mutterhaus der Borromaerinnen
  - Tuebingen, Germany, D-72076
    - Universitaetsklinikum Tuebingen
  - Ulm, Germany, D-89075
    - Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  - Vechta, Germany, D-49377
    - St. Marienhospital - Vechta
  - Vechta, Germany, D-49377
    - Staedtisches Klinikum - Howedestrase
  - Wiesbaden, Germany, D-65199
    - Dr. Horst-Schmidt-Kliniken
  - Wilhelmshaven, Germany, D-26389
    - Reinhard-Nieter-Krankenhaus
  - Wolfsburg, Germany, D-38440
    - Klinikum der Stadt Wolfsburg
  - Wuerzburg, Germany, D-97080
    - Universitaets - Kinderklinik Wuerzburg
  - Wuppertal, Germany, D-42283
    - Helios Kliniken Wuppertal University Hospital
Sweden
- - Jonkoping, Sweden, S-55185
    - Länssjukhuset Ryhov
Switzerland
- - Aarau, Switzerland, CH-5001
    - Kantonspital Aarau
  - Basel, Switzerland, CH-4005
    - Universitaets-Kinderspital beider Basel
  - Locarno, Switzerland, 6600
    - Ospedale "la Carita", Locarno
  - Lucerne 16, Switzerland, CH-6000
    - Kinderspital Luzern
  - St. Gallen, Switzerland, 9006
    - Ostschweizer Kinderspital
  - Winterthur, Switzerland, CH-8400
    - Kantonsspital Winterthur
  - Zurich, Switzerland, CH-8032
    - University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators

Study Chair: Hermann Mueller, MD, Klinikum Oldenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GPOH-CRANIOPHARYNGIOMA-2000
CDR0000450768 (Registry Identifier: PDQ (Physician Data Query))
EU-20537

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.