Clinical Trial: Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational - Identifying and Validating Novel Mechanisms of Radiation Resistance in Rhabdomyosarcoma

Brief 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. It may also help doctors find better ways to treat cancer

Detailed Summary:

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).


Sponsor: Children's Oncology Group

Current 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 ]


Original Primary Outcome:

  • Molecular response/resistance signatures of radiotherapy and standard chemoradiation using Spearman's rho
  • Novel pathway/biomarkers associated with clinical response
  • Novel pathway/biomarkers associated with local control rates using log-rank and univariate/multivariate Cox regression analysis
  • Novel pathway/biomarkers associated with overall survival rates using log-rank and univariate/multivariate Cox regression analysis


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: June 20, 2012
Date Started: June 2012
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016