Adult RhabdomyosarcomaNCT01668095
Biomarkers in Patients With Advanced Rhabdomyosarcoma
An observational study of Adult Rhabdomyosarcoma and Childhood Alveolar Rhabdomyosarcoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2012
- 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 with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment.
Who may be able to join
- 8 tissue microarrays (TMA) slides of the following diseases available:
- Alveolar rhabdomyosarcoma
- Embryonal rhabdomyosarcoma
- Anaplastic rhabdomyosarcoma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Philadelphia, Pennsylvania, 19104
About this study
Official title: Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas
This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.
OUTLINE:
Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.
- Conditions
- Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Rhabdomyosarcoma, 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 |
|---|---|---|
| Ancillary-Correlative (biomarker analysis) | Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult RhabdomyosarcomaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Keller, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668095
- Sponsor's protocol ID
- ARST12B8
- Other IDs
- NCI-2012-01997, COG-ARST12B8, CDR0000738499, ARST12B8, ARST12B8
- Status last verified
- May 2016
- First submitted
- 15 Aug 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
- Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas
- ClinicalTrials.gov ID
- NCT01668095
- Acronym / sponsor ID
- ARST12B8
- Conditions
- Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 17 Aug 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.
This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.
OUTLINE:
Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biomarker analysis) | – | Other: Laboratory Biomarker AnalysisImmunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment.
Key inclusion criteria (4 listed)
- 8 tissue microarrays (TMA) slides of the following diseases available:
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 | Ancillary-Correlative (biomarker analysis) |
Primary outcome
Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma
Time frame: 1 month
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.
Charles Keller, 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 Adult Rhabdomyosarcoma and Childhood Alveolar Rhabdomyosarcoma, 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 4 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 18 May 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?
Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma (time frame: 1 month). 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.