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

Recurrent Childhood Rhabdomyosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626170
• Other study ID #: ARST12B6
• Secondary ID: NCI-2012-01979
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: July 13, 2016
• Start date: June 2012

Study information

• Verified date: July 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alveolar Childhood Rhabdomyosarcoma
• Embryonal Childhood Rhabdomyosarcoma
• Previously Treated Childhood Rhabdomyosarcoma
• Previously Untreated Childhood Rhabdomyosarcoma
• Recurrent Childhood Rhabdomyosarcoma
• Rhabdomyosarcoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular response		Up to 1 year	No
Primary	Novel pathway/biomarkers detected within clinically annotated patient tumor tissue samples		Up to 1 year	No