SarcomaNCT01342783
Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma
An observational study of Sarcoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- DNA analysis, RNA analysis and mutation analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: COG-D9902 soft tissue sarcoma biology and banking study participants.
DISEASE CHARACTERISTICS:
- Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
- Rhabdomyosarcoma, NOS
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Next Generation Sequencing of Childhood Soft Tissue Sarcomas to Identify Drivers of Primary and Metastatic Disease
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.
Read the detailed description
OBJECTIVES:
- To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
- To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.
OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.
- Conditions
- Sarcoma
- Being tested
- DNA analysis, RNA analysis, mutation analysis, nucleic acid sequencing, laboratory biomarker analysis
- Keywords
- metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
RNA analysisGenetic
mutation analysisGenetic
nucleic acid sequencingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Poul Sorensen, MD, PhD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342783
- Sponsor's protocol ID
- ARST11B2
- Other IDs
- COG-ARST11B2, NCI-2011-02853, ARST11B2
- Status last verified
- May 2016
- First submitted
- 23 Apr 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing of Childhood Soft Tissue Sarcomas to Identify Drivers of Primary and Metastatic Disease
- ClinicalTrials.gov ID
- NCT01342783
- Acronym / sponsor ID
- ARST11B2
- Conditions
- Sarcoma
- Keywords
- metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- May 2016 (actual)
- First posted
- 27 Apr 2011 (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.
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.
Detailed description
OBJECTIVES:
- To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
- To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.
OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- COG-D9902 soft tissue sarcoma biology and banking study participants.
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| RNA analysis | Genetic | – |
| mutation analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
Poul Sorensen, MD, PhD principal investigator
British Columbia Cancer Agency
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually. 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 18 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.