Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University Hospital Muenster German Federal Ministry of Education and Research |
---|---|
Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00824083 |
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: | Cohort, Prospective |
Official Title: | Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment |
Estimated Enrollment: | 2200 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2014 |
Groups/Cohorts |
---|
1
sarcoma survivors
|
2
healthy subjects
|
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.
Ages Eligible for Study: | 6 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Ewing sarcoma survivors and 1:1 matched control group of healthy subjects
Inclusion Criteria:
Exclusion Criteria:
Contact: Andreas Ranft, Dr. | 0049-251-8356486 | andreas.ranft@ukmuenster.de |
Contact: Christiane Hoffmann, Dr. | 0049-251-8356485 | Christiane.Hoffmann@ukmuenster.de |
Germany, North Rhine Westphalia | |
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 |
Principal Investigator: | Heribert Jürgens, Prof. | University Hospital Muenster |
Principal Investigator: | Dieter Rosenbaum, Prof. | University Hospital Muenster |
Responsible Party: | University Hospital Muenster ( Prof. Heribert Jürgens ) |
Study ID Numbers: | 01ER0807 |
Study First Received: | January 15, 2009 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00824083 History of Changes |
Health Authority: | Germany: Ethics Commission; Germany: Federal Ministry of Education and Research |
bone tumors long-term function daily activity late sequelae |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma, Ewing's Bone Neoplasms |
Sarcoma Osteogenic Sarcoma Osteosarcoma Ewing's Family of Tumors Ewing's Sarcoma |
Neoplasms, Connective and Soft Tissue Neoplasms Sarcoma, Ewing's Neoplasms by Histologic Type |
Neoplasms, Bone Tissue Sarcoma Osteosarcoma Neoplasms, Connective Tissue |