Soft Tissue and Bone TumorsNCT02199938
Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
An observational study of Soft Tissue and Bone Tumors and Sarcoma, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue and Bone Tumors, Sarcoma, Sarcoma of Bone
- What is being tested?
- Identification and characterization of molecular markers in musculoskeletal tumors
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jul 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who receive a biopsy or surgery because of confirmed or suspected musculoskeletal tumor.
Who may be able to join
- surgery or biopsy of a bone- or soft tissue tumor
- informed consent
Who cannot join
- patients wish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Identification and characterization of molecular markers in musculoskeletal tumors
- Medical subject headings
- Bone Neoplasms, Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification and characterization of molecular markers in musculoskeletal tumorsOther
| Study group | Role | What they receive |
|---|---|---|
| musculoskeletal tumors | Patients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery Receives: Other: Identification and characterization of molecular markers in musculoskeletal tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor RNA in resected tissue
Measured: at time of surgery
Secondary outcomes (2)
Cell free tumor RNA in blood plasma
Measured: 7 to 1 day before surgery
Cell free tumor RNA in blood plasma
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Principal Investigator has left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue and Bone TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199938
- Sponsor's protocol ID
- EK 10/2007 (5)
- Status last verified
- Sep 2018
- First submitted
- 1 Jul 2014
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Molecular Markers in Musculoskeletal Tumors
- ClinicalTrials.gov ID
- NCT02199938
- Acronym / sponsor ID
- EK 10/2007 (5)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator has left the Institution
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| musculoskeletal tumors | – | Other: Identification and characterization of molecular markers in musculoskeletal tumorsPatients with suspected or confirmed bone or soft tissue tumors undergoing biopsy or surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who receive a biopsy or surgery because of confirmed or suspected musculoskeletal tumor.
Key inclusion criteria (2 listed)
- surgery or biopsy of a bone- or soft tissue tumor
- informed consent
Key exclusion criteria (1 listed)
- patients wish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification and characterization of molecular markers in musculoskeletal tumors | Other | musculoskeletal tumors |
Primary outcome
Tumor RNA in resected tissue
Time frame: at time of surgery
2 secondary outcomes
Cell free tumor RNA in blood plasma
Time frame: 7 to 1 day before surgery
Cell free tumor RNA in blood plasma
Time frame: 1 day after surgery
Results and safety
The study was stopped early (reason given: Principal Investigator has left the Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Soft Tissue and Bone Tumors
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue and Bone Tumors and Sarcoma, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator has left the Institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor RNA in resected tissue (time frame: at time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.