Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

Sponsor

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany (Other)

Overall Status

Completed

CT.gov ID

NCT00258453

Collaborator

(none)

120

Enrollment

109

Locations

100

Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Krankenhaus Dornbirn	Dornbirn	Austria	A-6850
2	Landeskrankenhaus Feldkirch	Feldkirch-Tisis	Austria	A-6807
3	Universitaet Kinderklinik	Graz	Austria	8036
4	Innsbruck Universitaetsklinik	Innsbruck	Austria	A-6020
5	Landeskrankenhaus Klagenfurt	Klagenfurt	Austria	9026
6	LKH Leoben	Leoben	Austria	A-8700
7	A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung	Linz	Austria	4010
8	Landes-Kinderkrankenhaus	Linz	Austria	A-4020
9	St. Johanns-Spital	Salzburg	Austria	A-5020
10	Kardinal Schwarzenbersches Krankenhaus Betriebsgesellschraft mbH Kinderspital	Schwarzach	Austria	5620
11	A. oe. Landeskrankenhaus Abt. fuer Kinderkrankheiten	Steyr	Austria	4400
12	St. Anna Children's Hospital	Vienna	Austria	A-1090
13	Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik	Wien	Austria	1090
14	Kinderklinik - Universitaetsklinikum Aachen	Aachen	Germany	D-52074
15	Klinikum Augsburg	Augsburg	Germany	D-86156
16	Caritas-Krankenhaus Bad Mergentheim	Bad Mergentheim	Germany	D-97980
17	Klinikum am Bamberg	Bamberg	Germany	96049
18	Klinikum Bayreuth	Bayreuth	Germany	D-95445
19	Helios Klinikum Berlin	Berlin	Germany	13125
20	Charite - Campus Charite Mitte	Berlin	Germany	D-10117
21	Charite University Hospital - Campus Virchow Klinikum	Berlin	Germany	D-13353
22	Evangelisches Krankenhauus Bielfeld	Biefeld	Germany	33617
23	Kinderklinik der Universitaet Bonn	Bonn	Germany	D-53113
24	Klinikum Bremen-Mitte	Bremen	Germany	D-28205
25	Allgemeinen Krankenhaus Celle Kinderklinik	Celle	Germany	29223
26	Klinikum Chemnitz gGmbH	Chemnitz	Germany	D-09116
27	Klinikum Coburg	Coburg	Germany	96450
28	Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl	Cologne	Germany	D-50735
29	Children's Hospital	Cologne	Germany	D-50924
30	Carl - Thiem - Klinkum Cottbus	Cottbus	Germany	D-03048
31	Vestische Kinderklinik Universitaetsklinik Witten/Herdecke	Datteln	Germany	45711
32	Klinikum Lippe - Detmold	Detmold	Germany	D-32756
33	Staedtisches Krankenhaus Dresden - Neustadt	Dresden	Germany	D-01129
34	Universitatsklinikum Carl Gustav Carus	Dresden	Germany	D-01307
35	Klinikum Duisburg	Duisburg	Germany	D-47055
36	Klinikum Erfurt	Erfurt	Germany	99089
37	Universitaets - Kinderklinik	Erlangen	Germany	D-91054
38	Klinikum der J.W. Goethe Universitaet	Frankfurt	Germany	D-60590
39	Universitaetskinderklinik - Universitaetsklinikum Freiburg	Freiburg	Germany	D-79106
40	Kinderklinik	Giessen	Germany	D-35385
41	Universitaetsklinikum Goettingen	Goettingen	Germany	D-37075
42	Universitats - Kinderklinik	Greiswald	Germany	17487
43	Kreiskrankenhaus Gummersbach GMBH	Gummersbach	Germany	D-51643
44	Universitaetsklinikum Halle	Halle	Germany	D-06097
45	University Medical Center Hamburg - Eppendorf	Hamburg	Germany	D-20246
46	Medizinische Hochschule Hannover	Hannover	Germany	D-30625
47	Universitaets-Kinderklinik Heidelberg	Heidelberg	Germany	D-69120
48	Kreskrankenhaus Kinderabteilung	Heide	Germany	25746
49	SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen	Heilbronn	Germany	D-74064
50	Gemeinschaftskrankenhaus	Herdecke	Germany	58313
51	Staedtisches Krankenhaus Hildesheim	Hildesheim	Germany	D-31134
52	Universitaetsklinikum des Saarlandes	Homburg	Germany	66421
53	Clinic for Bone Marrow Transplantation and Hematology and Oncology	Idar-Oberstein	Germany	D-55743
54	Universitaets - Kinderklinik	Jena	Germany	D-07745
55	Municipal Hospital Complex of the University	Kaiserslautern	Germany	67655
56	Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany	76133
57	Klinikum Kassel	Kassel	Germany	D-34125
58	Staedtisches Krankenhaus Kiel	Kiel	Germany	23116
59	University Hospital Schleswig-Holstein - Kiel Campus	Kiel	Germany	D-24105
60	Klinikum Kemperhof Koblenz	Koblenz	Germany	D-56065
61	Klinik Konstanz	Konstanz	Germany	78461
62	Klinikum Krefeld GmbH	Krefeld	Germany	D-47805
63	Kinderkrankenhaus St. Marien	Landshut	Germany	84036
64	Universitaets - Kinderklinik	Leipzig	Germany	D-04317
65	St. Annastift Krankenhaus	Ludwigshafen	Germany	67065
66	Universitaets - Kinderklinik - Luebeck	Luebeck	Germany	D-23538
67	Universitatsklinikum der MA	Magdeburg	Germany	39112
68	Johannes Gutenberg University	Mainz	Germany	D-55131
69	Staedtisches Klinik - Kinderklinik	Mannheim	Germany	D-68167
70	Universitaets - Kinderklinik	Marburg	Germany	35033
71	Klinikum Minden	Minden	Germany	D-32423
72	Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin	Moenchengladbach	Germany	D-41066
73	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster	Muenster	Germany	D-48149
74	Krankenhaus Muenchen Schwabing	Munich	Germany	80804
75	Dr. von Haunersches Kinderspital der Universitaet Muenchen	Munich	Germany	D-80337
76	Staedtisches Krankenhaus Muenchen - Harlaching	Munich	Germany	D-81545
77	Klinikum Neubrandenburg	Neubrandenburg	Germany	17036
78	Lukaskrankenhaus Neuss	Neuss	Germany	D-41464
79	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied	Germany	56564
80	Cnopf'sche Kinderklinik	Nuremberg	Germany	90419
81	Klinikum Nuernberg - Klinikum Sued	Nuremberg	Germany	D-90471
82	Klinikum Oldenburg	Oldenburg	Germany	26133
83	Marien Hospital	Osnabruck	Germany	D-49074
84	Paracelsus - Klinik Osnabrueck	Osnabrueck	Germany	D-49076
85	Klinik St. Hedwig-Kinderklinik	Regensburg	Germany	93049
86	Kinderklinik - Universitaetsklinikum Rostock	Rostock	Germany	D-18057
87	Saarbrucker Winterbergkliniken	Saarbrucken	Germany	66119
88	Klinikum Schwerin	Schwerin	Germany	D-19049
89	Kinderklink Siegen Deutsches Rotes Kreuz	Siegen	Germany	D-57072
90	Johanniter-Kinderklinik	St. Augustin	Germany	53757
91	Olgahospital	Stuttgart	Germany	D-70176
92	Krankenanstalt Mutterhaus der Borromaerinnen	Trier	Germany	D-54290
93	Universitaetsklinikum Tuebingen	Tuebingen	Germany	D-72076
94	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm	Ulm	Germany	D-89075
95	St. Marienhospital - Vechta	Vechta	Germany	D-49377
96	Staedtisches Klinikum - Howedestrase	Vechta	Germany	D-49377
97	Dr. Horst-Schmidt-Kliniken	Wiesbaden	Germany	D-65199
98	Reinhard-Nieter-Krankenhaus	Wilhelmshaven	Germany	D-26389
99	Klinikum der Stadt Wolfsburg	Wolfsburg	Germany	D-38440
100	Universitaets - Kinderklinik Wuerzburg	Wuerzburg	Germany	D-97080
101	Helios Kliniken Wuppertal University Hospital	Wuppertal	Germany	D-42283
102	Lanssjukhuset Ryhov	Jonkoping	Sweden	S-55185
103	Kantonspital Aarau	Aarau	Switzerland	CH-5001
104	Universitaets-Kinderspital beider Basel	Basel	Switzerland	CH-4005
105	Ospedale "la Carita", Locarno	Locarno	Switzerland	6600
106	Kinderspital Luzern	Lucerne 16	Switzerland	CH-6000
107	Ostschweizer Kinderspital	St. Gallen	Switzerland	9006
108	Kantonsspital Winterthur	Winterthur	Switzerland	CH-8400
109	University Children's Hospital	Zurich	Switzerland	CH-8032