Identification and Characterization of Molecular Markers in Musculoskeletal Tumors

September 30, 2018 updated by: Balgrist University Hospital
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.

Study Overview

Status

Terminated

Conditions

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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who receive a biopsy or surgery because of confirmed or suspected musculoskeletal tumor.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients wish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Identification and characterization of molecular markers in musculoskeletal tumors

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

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 30, 2018

Last Verified

September 1, 2018

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)?

UNDECIDED

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.

Clinical Trials on Sarcoma

Clinical Trials on Identification and characterization of molecular markers in musculoskeletal tumors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe