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
  Purpose
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.

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:
  • physical activity (SAM: step-activity-monitor) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 950
Study Start Date: July 2009
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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 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.

  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 1:2 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
  • <3y 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

Locations
Germany
Department of Pediatric Hematology and Oncology, University Children's Hospital
Muenster, North Rhine Westphalia, Germany, 48129
Motion Analysis Lab, Orthopedic Department, University Hospital
Münster, North Rhine Westphalia, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Andreas Ranft, Dr. University Hospital Muenster
Study Chair: Heribert Jürgens, Prof. University Hospital Muenster
  More Information

Publications:

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00824083     History of Changes
Other Study ID Numbers: 01ER0807 
Study First Received: January 15, 2009
Last Updated: April 27, 2016
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
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Osteosarcoma

ClinicalTrials.gov processed this record on April 27, 2016