SarcomaNCT01430637
Studying Genes in Samples From Younger Patients With Desmoplastic Small Round Cell Tumor Registered on COG-D9902 or COG-ABTR01B1
An observational study of Sarcoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tumor tissue 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?
- Ages Up to 50 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- DNA analysis, RNA analysis and gene expression analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients registered on COG-D9902 or COG-ABTR01B1.
DISEASE CHARACTERISTICS:
- Tumor and blood samples from patients registered on COG-D9902 or COG-ABTR01B1 obtained from the Cooperative Human Tissue Network (CHTN) and the Children's Oncology Group (COG) tumor banks
- Matched normal samples
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Comprehensive Genome Sequencing of Desmoplastic Small Round Cell Tumors
RATIONALE: Studying samples of blood and tumor tissue 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 studying genes in samples from younger patients with desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.
Read the detailed description
OBJECTIVES:
- To perform whole-exome sequencing on desmoplastic small round cell tumor (DSRCT) samples and their available matched normal samples to identify novel mutations, single nucleotide polymorphisms, or copy number changes associated with these tumors.
- To identify regions of interest that may be involved in the pathogenesis (including the region of EWSR1-WT1 translocation) from the whole-exome sequencing and perform detailed resequencing and transcriptone sequencing to further define the molecular aberrations at the RNA level.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for DNA sequencing, effects of RNA on gene expression levels, novel RNA isoforms, splice variants, and translocations.
- Conditions
- Sarcoma
- Being tested
- DNA analysis, RNA analysis, gene expression analysis, mutation analysis, nucleic acid sequencing
- Keywords
- childhood desmoplastic small round cell tumor, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, adult desmoplastic small round cell tumor
- Medical subject headings
- Sarcoma, Desmoplastic Small Round Cell Tumor
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
mutation analysisGenetic
nucleic acid sequencingGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
pharmacogenomic studiesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of novel mutations, single nucleotide polymorphisms, and copy number changes associated with DSRCT
Identification of genomic regions involved in pathogenesis of DSRCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 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-control
- 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
- Pooja Hingorani, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430637
- Sponsor's protocol ID
- ARST11B5
- Other IDs
- COG-ARST11B5, ARST11B5, NCI-2011-03455
- Status last verified
- May 2016
- First submitted
- 7 Sep 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
- Comprehensive Genome Sequencing of Desmoplastic Small Round Cell Tumors
- ClinicalTrials.gov ID
- NCT01430637
- Acronym / sponsor ID
- ARST11B5
- Conditions
- Sarcoma
- Keywords
- childhood desmoplastic small round cell tumor, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- May 2016 (actual)
- First posted
- 8 Sep 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 blood and tumor tissue 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 studying genes in samples from younger patients with desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.
Detailed description
OBJECTIVES:
- To perform whole-exome sequencing on desmoplastic small round cell tumor (DSRCT) samples and their available matched normal samples to identify novel mutations, single nucleotide polymorphisms, or copy number changes associated with these tumors.
- To identify regions of interest that may be involved in the pathogenesis (including the region of EWSR1-WT1 translocation) from the whole-exome sequencing and perform detailed resequencing and transcriptone sequencing to further define the molecular aberrations at the RNA level.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for DNA sequencing, effects of RNA on gene expression levels, novel RNA isoforms, splice variants, and translocations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients registered on COG-D9902 or COG-ABTR01B1.
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 | – |
| mutation analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacogenomic studies | Other | – |
Primary outcome
Identification of novel mutations, single nucleotide polymorphisms, and copy number changes associated with DSRCT
Identification of genomic regions involved in pathogenesis of DSRCT
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.
Pooja Hingorani, MD principal investigator
Phoenix Children's Hospital
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?
Identification of novel mutations, single nucleotide polymorphisms, and copy number changes associated with DSRCT. The study lists 2 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 18 May 2016.