Alveolar Childhood RhabdomyosarcomaNCT01626170
Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma
An observational study of Alveolar Childhood Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma. Studying samples of 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?
- Any age
- Conditions the study is for
- Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2013
- 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 enrolled on COG-D9902.
Who may be able to join
- Tissues requested from the Children Oncology Group (COG) sarcoma banking protocol COG-D9902
- All subtypes of rhabdomyosarcoma specimens
- Matched primary-relapsed specimens (from same patient, separated by time):
- Frozen tissue if available
- Scrolls of formalin-fixed paraffin-embedded tissue (if frozen not available)
- 10 unstained formalin-fixed paraffin-embedded thin sections
- All other general (primary or relapsed) cases
- 10 unstained formalin-fixed paraffin-embedded thin sections
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 - Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma
This laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma. Studying samples of 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. It may also help doctors find better ways to treat cancer
Read the detailed description
Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples with DNA Biospecimen Description: Tissue Study Population Description: Primary care clinic Sampling Method: Non-probability sample
OBJECTIVES:
- Determine the molecular response/resistance signatures with radiotherapy and standard chemoradiation treatments using the xenograft model of the Pediatric Preclinical Testing Program (PPTP).
II. Validate these novel pathways/biomarkers by their detection within clinically annotated patient tumor tissue samples and testing their associations with clinical response, local control rates, and overall survival rates.
OUTLINE: Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH).
- Conditions
- Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma
- Being tested
- laboratory biomarker analysis
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 |
|---|---|---|
| Correlative (laboratory biomarker analysis) | Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH). Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular response
Measured: Up to 1 year
Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Childhood 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
- Cohort
- 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
- Christopher Pelloski, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626170
- Sponsor's protocol ID
- ARST12B6
- Other IDs
- NCI-2012-01979
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2012
- 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 - Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT01626170
- Acronym / sponsor ID
- ARST12B6
- Conditions
- Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- First posted
- 22 Jun 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 laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma. Studying samples of 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. It may also help doctors find better ways to treat cancer
Detailed description
Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples with DNA Biospecimen Description: Tissue Study Population Description: Primary care clinic Sampling Method: Non-probability sample
OBJECTIVES:
- Determine the molecular response/resistance signatures with radiotherapy and standard chemoradiation treatments using the xenograft model of the Pediatric Preclinical Testing Program (PPTP).
II. Validate these novel pathways/biomarkers by their detection within clinically annotated patient tumor tissue samples and testing their associations with clinical response, local control rates, and overall survival rates.
OUTLINE: Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlative (laboratory biomarker analysis) | – | Other: laboratory biomarker analysisArchived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rhabdomyosarcoma enrolled on COG-D9902.
Key inclusion criteria (8 listed)
- Tissues requested from the Children Oncology Group (COG) sarcoma banking protocol COG-D9902
- All subtypes of rhabdomyosarcoma specimens
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 | Correlative (laboratory biomarker analysis) |
Primary outcome
Molecular response
Time frame: Up to 1 year
Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples
Time frame: Up to 1 year
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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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
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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.
Christopher Pelloski, 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 Alveolar Childhood Rhabdomyosarcoma and Embryonal Childhood 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 8 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?
Molecular response (time frame: Up to 1 year). 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 14 Jul 2016.