- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626170
Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma
Observational - Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma
Study Overview
Status
Conditions
Intervention / Treatment
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:
I. 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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).
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Molecular response
Time Frame: Up to 1 year
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Up to 1 year
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Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples
Time Frame: Up to 1 year
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Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Pelloski, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARST12B6
- NCI-2012-01979 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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