Identification and Characterization of Molecular Markers in Musculoskeletal Tumors

Terminated

• Conditions: Soft Tissue and Bone Tumors; Soft Tissue Sarcoma; Sarcoma; Sarcoma of Bone
• Interventions: Other: Identification and characterization of molecular markers in musculoskeletal tumors

• Registration Number: NCT02199938
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• patients wish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
musculoskeletal tumors	Identification and characterization of molecular markers in musculoskeletal tumors	Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery

Primary Outcome Measures

Name	Time	Method
Tumor RNA in resected tissue	at time of surgery

Secondary Outcome Measures

Name	Time	Method
Cell free tumor RNA in blood plasma	1 day after surgery

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland