NCT02199938

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

8.5 years

First QC Date

July 1, 2014

Last Update Submit

September 30, 2018

Conditions

Soft Tissue and Bone TumorsSarcomaSarcoma of BoneSoft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Tumor RNA in resected tissue

    at time of surgery

Secondary Outcomes (2)

  • Cell free tumor RNA in blood plasma

    7 to 1 day before surgery

  • Cell free tumor RNA in blood plasma

    1 day after surgery

Study Arms (1)

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

Interventions

Identification and characterization of molecular markers in musculoskeletal tumorsOTHER
musculoskeletal tumors

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients wish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood serum blood plasma tumor tissue tumor free tissue

MeSH Terms

Conditions

Bone NeoplasmsSarcomaOsteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Bone TissueNeoplasms, Connective Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 25, 2014

Study Start

January 1, 2010

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

CH(1)