Soft Tissue SarcomaNCT01802125
Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas
An observational study of Soft Tissue Sarcoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2014
- 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: Undifferentiated sarcomas from ARST0332
Who may be able to join
- 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Observational - SNP Array Analysis of Undifferentiated Sarcomas
This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Read the detailed description
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample
PRIMARY OBJECTIVES:
- To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed.
II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma.
III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features.
IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features.
OUTLINE:
Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- laboratory biomarker analysis
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic science (SNP array analysis) | Tissue samples are analyzed using laboratory biomarker analysis for LOH and SNP array profiling using microarray and immunohistochemistry. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of unclassifiable sarcomas that are unclassifiable
Measured: Baseline
Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma
Measured: Baseline
Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features
Measured: Baseline
Specific "actionable mutations" that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia Bridge, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802125
- Sponsor's protocol ID
- ARST12B9
- Other IDs
- NCI-2013-00489
- Status last verified
- Jul 2016
- First submitted
- 27 Feb 2013
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational - SNP Array Analysis of Undifferentiated Sarcomas
- ClinicalTrials.gov ID
- NCT01802125
- Acronym / sponsor ID
- ARST12B9
- Conditions
- Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 1 Mar 2013 (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.
This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Detailed description
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample
PRIMARY OBJECTIVES:
- To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed.
II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma.
III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features.
IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features.
OUTLINE:
Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (SNP array analysis) | – | Other: laboratory biomarker analysisTissue samples are analyzed using laboratory biomarker analysis for LOH and SNP array profiling using microarray and immunohistochemistry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Undifferentiated sarcomas from ARST0332
Key inclusion criteria (1 listed)
- 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Basic science (SNP array analysis) |
Primary outcome
Proportion of unclassifiable sarcomas that are unclassifiable
Time frame: Baseline
Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma
Time frame: Baseline
Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features
Time frame: Baseline
Specific "actionable mutations" that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features
Time frame: Baseline
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 14 Jul 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.
Julia Bridge, MD principal investigator
Children's Oncology Group
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 Sarcoma, run by Children's Oncology Group at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 14 Jul 2016. 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 United States. 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 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?
Proportion of unclassifiable sarcomas that are unclassifiable (time frame: Baseline). 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 14 Jul 2016.