Identification and Characterization of Molecular Markers in Musculoskeletal Tumors

Sarcoma Clinical Trial

Official title:

Identification and Characterization of Molecular Markers in Musculoskeletal Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02199938
• Other study ID #: EK 10/2007 (5)
• Status: Terminated
• Start date: January 2010
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• informed consent

Exclusion Criteria:

• patients wish

Related Conditions & MeSH terms

• Neoplasms, Connective and Soft Tissue
• Sarcoma
• Sarcoma of Bone
• Soft Tissue and Bone Tumors
• Soft Tissue Sarcoma

Intervention

Other:
• Identification and characterization of molecular markers in musculoskeletal tumors

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor RNA in resected tissue		at time of surgery
Secondary	Cell free tumor RNA in blood plasma		7 to 1 day before surgery
Secondary	Cell free tumor RNA in blood plasma		1 day after surgery