Clinical trial NCT02199938: Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
Official title: Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Soft Tissue and Bone Tumors
Sarcoma
Sarcoma of Bone
Soft Tissue Sarcoma
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who receive a biopsy or surgery because of confirmed or suspected musculoskeletal tumor.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients wish

Primary outcomes:
measure: Tumor RNA in resected tissue
timeFrame: at time of surgery
Secondary outcomes:
measure: Cell free tumor RNA in blood plasma
timeFrame: 7 to 1 day before surgery
measure: Cell free tumor RNA in blood plasma
timeFrame: 1 day after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References: