SarcomaNCT01585376
Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma
An observational study of Sarcoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- mutation analysis, nucleic acid sequencing and laboratory biomarker analysis
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with rhabdomyosarcoma
DISEASE CHARACTERISTICS:
- Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Study Recurrency Testing of Mutations Identified in WGS of Pediatric Rhabdomyosarcoma
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.
Read the detailed description
OBJECTIVES:
- To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions.
- To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma.
OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.
- Conditions
- Sarcoma
- Being tested
- mutation analysis, nucleic acid sequencing, laboratory biomarker analysis
- Keywords
- alveolar childhood rhabdomyosarcoma, embryonal 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.
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.
Frequency of particular genetic lesions
Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016
- Study 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alberto S. Pappo, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585376
- Sponsor's protocol ID
- ARST12B3
- Other IDs
- COG-ARST12B3, ARST12B3, CDR0000732173, NCI-2012-00729
- Status last verified
- May 2016
- First submitted
- 24 Apr 2012
- 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
- Study Recurrency Testing of Mutations Identified in WGS of Pediatric Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT01585376
- Acronym / sponsor ID
- ARST12B3
- Conditions
- Sarcoma
- Keywords
- alveolar childhood rhabdomyosarcoma, embryonal childhood rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Apr 2012 (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 tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.
Detailed description
OBJECTIVES:
- To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions.
- To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma.
OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with rhabdomyosarcoma
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 |
|---|---|---|
| mutation analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Frequency of particular genetic lesions
Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole
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.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
Active, not recruitingPhase 2
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Synovial Sarcoma, Myxoid Liposarcoma
RecruitingPhase 2
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, AXIOM Trial
Advanced Alveolar Soft Part Sarcoma, Advanced Soft Tissue Sarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
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.
Alberto S. Pappo, MD principal investigator
St. Jude Children's Research 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.
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?
Frequency of particular genetic lesions. 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; AzTrials last refreshed its copy on 6 Nov 2026.