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Identification and Characterization of Molecular Markers in Musculoskeletal Tumors

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ClinicalTrials.gov Identifier: NCT02199938
Recruitment Status : Recruiting
First Posted : July 25, 2014
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief Summary:
The aim of the study is to improve the understanding of molecular mechanisms in the development and progression of musculoskeletal tumors. These tumors do have in general unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or chemotherapy) could not enhance the prognosis of these patients during the last ten to fifteen years. Therefore the investigators chose a new way, as they try to identify markers on a genetic level, who ideally act as a basis to develop new treatment options.

Condition or disease Intervention/treatment
Soft Tissue and Bone Tumors Other: Identification and characterization of molecular markers in musculoskeletal tumors

Detailed Description:

To definitely asses such molecular markers in musculoskeletal tumors they have to be identified in human patient samples with corresponding tumors, before molecular markers can be validated in animal models. Just because these soft tissue and bone tumors are rare (compared to breast and lung carcinomas), it is of great importance that samples from all patients treated at Balgrist University Hospital are collected systematically und stored correspondingly. Only like this valid statements can be done. Therefore the investigators intent to collect tissue and blood samples from all patients who agree in participating in the study. The samples will be taken during routine biopsies and operations. To compare tumor tissue and healthy tissue it is also planed to take samples from tumor free patients who undergo a knee replacement surgery. The investigators would store the surgical waste and involve these samples in the analyzes.

Clinical data regarding diagnosis and examination findings, as well as tissue from biopsies and surgeries will be collected prospectively. The tissue will be frozen in liquid nitrogen according to standard procedures and stored until the molecular analyzes at the Laboratory of Orthopedic Research at Balgrist University Hospital. The processing involves expression analyzes such as polymerase chain reaction, Western Blot, micro arrays, immunohistochemistry and tissue array. The DNA from the taken blood samples shall be compared with the DNA found in the tumor.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
Study Start Date : January 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Group/Cohort Intervention/treatment
musculoskeletal tumors
Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery
Other: Identification and characterization of molecular markers in musculoskeletal tumors



Primary Outcome Measures :
  1. Tumor RNA in resected tissue [ Time Frame: at time of surgery ]

Secondary Outcome Measures :
  1. Cell free tumor RNA in blood plasma [ Time Frame: 7 to 1 day before surgery ]
  2. Cell free tumor RNA in blood plasma [ Time Frame: 1 day after surgery ]

Biospecimen Retention:   Samples With DNA
blood serum blood plasma tumor tissue tumor free tissue


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive a biopsy or surgery because of confirmed or suspected musculoskeletal tumor.
Criteria

Inclusion Criteria:

  • surgery or biopsy of a bone- or soft tissue tumor
  • informed consent

Exclusion Criteria:

  • patients wish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199938


Locations
Switzerland
Balgrist University Hospital Recruiting
Zurich, Switzerland, 8008
Contact: Bruno Fuchs, MD PhD    0443861663 ext 01141    bruno.fuchs@balgrist.ch   
Principal Investigator: Bruno Fuchs, MD PhD         
Sponsors and Collaborators
Balgrist University Hospital
Investigators
Principal Investigator: Bruno Fuchs, MD PhD Balgrist University Hospital

Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02199938     History of Changes
Other Study ID Numbers: EK 10/2007 (5)
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms