Observation of Young Patients Who Are Undergoing Surgery... | NCT00258453

Studies
Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma

NCT00258453

Sponsor

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Status

Completed

Last Update Posted

Aug 2, 2013Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

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

Interventions

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

Countries

Austria
Germany
Sweden
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
CDR0000450768	Registry Identifier	PDQ (Physician Data Query)
EU-20537

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2009Actual

First Submitted Date

Nov 22, 2005

First Submission Date that Met QC Criteria

Nov 22, 2005

First Posted Date

Nov 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hermann Mueller, MD	Klinikum Oldenburg	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus Dornbirn		Dornbirn		A-6850	Austria
Landeskrankenhaus Feldkirch

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20379145	Result	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.
20197669	Result	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.

ID	Term
D016543	Central Nervous System Neoplasms
D011183	Postoperative Complications
D001836	Body Weight Changes

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001835	Body Weight
D012816	Signs and Symptoms

ID	Term
D001706	Biopsy
D009682	Magnetic Resonance Spectroscopy
D000067250	Psychiatric Rehabilitation
D011878	Radiotherapy

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling
D003949	Diagnostic Techniques, Surgical
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D012046	Rehabilitation
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Name	Type	Description	Arm Group Labels	Other Names
metabolic assessment	Other
physiologic testing	Other
biopsy	Procedure
computed tomography	Procedure
conventional surgery	Procedure
magnetic resonance imaging	Procedure
management of therapy complications	Procedure