Trial record 6 of 57 for:    Open Studies | "Sarcoma, Ewing's"

Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00824083
First received: January 15, 2009
Last updated: September 25, 2009
Last verified: July 2009
  Purpose

The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 1100 long-term survivors of Ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma patients with a follow-up of 3 decades.


Condition
Sarcoma, Ewing's

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • real-world daily activity (SAM: step-activity-monitor) [ Time Frame: 5-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health-related quality of life (SF36, PEDQOL) [ Time Frame: 5-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
  • functional status (TESS) [ Time Frame: 5-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
  • psychological status (HADS, BIS-BAS) [ Time Frame: 5-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Groups/Cohorts
1
sarcoma survivors
2
healthy subjects

Detailed Description:

Trial objective: As survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. This study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of Ewing sarcoma. The data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment.

Working plan: The working plan provides for the assessment of functional outcome and quality of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily activity patterns by using the Step Activity Monitor (SAM) in 1100 long-term Ewing sarcoma survivors and a control group of 1100 matched healthy subjects. Information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified.

Exploitation of results: The results will be presented at scientific meetings and will be published in international journals. Guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. In the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Ewing sarcoma survivors and 1:1 matched control group of healthy subjects

Criteria

Inclusion Criteria:

  • CESS81/CESS86/EICESS92/EURO-E.W.I.N.G.99 trials participants of the German Society of Pediatric Hematology and Oncology (GPOH)

Exclusion Criteria:

  • no complete remission (CR)
  • any kind of paralysis
  • <5y after diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824083

Contacts
Contact: Andreas Ranft, Dr. 0049-251-8356486 andreas.ranft@ukmuenster.de
Contact: Christiane Hoffmann, Dr. 0049-251-8356485 Christiane.Hoffmann@ukmuenster.de

Locations
Germany
Department of Pediatric Hematology and Oncology, University Children's Hospital Recruiting
Muenster, North Rhine Westphalia, Germany, 48129
Contact: Andreas Ranft, Dr.    0049-251-8356486    andreas.ranft@ukmuenster.de   
Contact: Christiane Hoffmann, Dr.    0049-251-8356485    Christiane.Hoffmann@ukmuenster.de   
Principal Investigator: Heribert Jürgens, Prof.         
Motion Analysis Lab, Orthopedic Department, University Hospital Recruiting
Münster, North Rhine Westphalia, Germany, 48129
Contact: Corinna Winter, MA    0049-251-8352975    winterco@uni-muenster.de   
Contact: Dieter Rosenbaum, Prof.    0049-251-8352970    diro@uni-muenster.de   
Principal Investigator: Dieter Rosenbaum, Prof.         
Sponsors and Collaborators
University Hospital Muenster
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Heribert Jürgens, Prof. University Hospital Muenster
Principal Investigator: Dieter Rosenbaum, Prof. University Hospital Muenster
  More Information

Publications:

Responsible Party: Prof. Heribert Jürgens, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00824083     History of Changes
Other Study ID Numbers: 01ER0807
Study First Received: January 15, 2009
Last Updated: September 25, 2009
Health Authority: Germany: Ethics Commission
Germany: Federal Ministry of Education and Research

Keywords provided by University Hospital Muenster:
bone tumors
long-term function
daily activity
late sequelae

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014