- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199938
Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8008
- Balgrist University Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- surgery or biopsy of a bone- or soft tissue tumor
- informed consent
Exclusion Criteria:
- patients wish
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
musculoskeletal tumors
Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor RNA in resected tissue
Time Frame: at time of surgery
|
at time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cell free tumor RNA in blood plasma
Time Frame: 7 to 1 day before surgery
|
7 to 1 day before surgery
|
Cell free tumor RNA in blood plasma
Time Frame: 1 day after surgery
|
1 day after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 10/2007 (5)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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