SarcomaNCT01062438
Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma
An observational study of Sarcoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- DNA analysis, RNA analysis and gene expression analysis
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosis of localized or metastatic osteosarcoma
DISEASE CHARACTERISTICS:
- Diagnosis of localized or metastatic osteosarcoma
- Banked snap-frozen tumor tissue samples and paired blood DNA samples available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Genomic Study of Metastatic Osteosarcoma Using Next-Generation Sequencing Technology
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.
Read the detailed description
OBJECTIVES:
- Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.
- Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.
- Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.
- Identify which mutations are associated with outcome.
- Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.
OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.
Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.
- Conditions
- Sarcoma
- Being tested
- DNA analysis, RNA analysis, gene expression analysis, gene rearrangement analysis, mutation analysis
- Keywords
- localized osteosarcoma, metastatic osteosarcoma
- Medical subject headings
- Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
RNA analysisGenetic
gene expression analysisGenetic
gene rearrangement analysisGenetic
mutation analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing
Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing
Mutations associated with outcome
Mutations also found in germ line DNA that predispose the patient to osteosarcoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Javed Khan, MD, Principal investigator, NCI - Oncogenomics Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062438
- Sponsor's protocol ID
- AOST10B3
- Other IDs
- COG-AOST10B3, CDR0000665327, NCI-2011-02210
- Status last verified
- May 2015
- First submitted
- 3 Feb 2010
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Study of Metastatic Osteosarcoma Using Next-Generation Sequencing Technology
- ClinicalTrials.gov ID
- NCT01062438
- Acronym / sponsor ID
- AOST10B3
- Conditions
- Sarcoma
- Keywords
- localized osteosarcoma, metastatic osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Feb 2010 (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 tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.
Detailed description
OBJECTIVES:
- Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.
- Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.
- Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.
- Identify which mutations are associated with outcome.
- Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.
OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.
Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis of localized or metastatic osteosarcoma
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 | – |
| gene expression analysis | Genetic | – |
| gene rearrangement analysis | Genetic | – |
| mutation analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing
Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing
Mutations associated with outcome
Mutations also found in germ line DNA that predispose the patient to osteosarcoma
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 6 May 2015.
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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.
Javed Khan, MD principal investigator
NCI - Oncogenomics Section
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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. 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?
Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing. The study lists 4 primary outcomes in all. 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 6 May 2015.