Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00824083
First received: January 15, 2009
Last updated: April 27, 2016
Last verified: April 2016

January 15, 2009
April 27, 2016
July 2009
July 2015   (final data collection date for primary outcome measure)
physical activity (SAM: step-activity-monitor) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
real-world daily activity (SAM: step-activity-monitor) [ Time Frame: 5-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00824083 on ClinicalTrials.gov Archive Site
  • health-related quality of life (SF36, PEDQOL) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
  • functional status (TESS) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
  • psychological status (HADS, BIS-BAS) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 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.

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 600 long-term Ewing sarcoma survivors and a control group of 300 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Ewing sarcoma survivors and 1:2 matched control group of healthy subjects
Sarcoma, Ewing's
Not Provided
  • 1
    sarcoma survivors
  • 2
    healthy subjects

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
950
July 2015
July 2015   (final data collection date for primary outcome measure)

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
  • <3y after diagnosis
Both
6 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00824083
01ER0807
No
No
Not Provided
University Hospital Muenster
University Hospital Muenster
German Federal Ministry of Education and Research
Principal Investigator: Andreas Ranft, Dr. University Hospital Muenster
Study Chair: Heribert Jürgens, Prof. University Hospital Muenster
University Hospital Muenster
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP