Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01609803
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 99
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This research trial studies protein expression in tissue 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.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Previously Untreated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma	Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

1. To investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (FISH) and immunohistochemical (IHC) assays to a panel of alveolar rhabdomyosarcomas (ARMS) cases organized into tissue microarrays.

OUTLINE:

Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Study Design

• Study Type: Observational
• Actual Enrollment: 99 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Correlative studies Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.	Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Amplification and fusion status as a result of the 12q13-q14 amplification event [Baseline]

   Fisher's exact test will be used. For a contingency table other than 2 x 2, the Freeman-Halton test (an extension of Fisher's exact test) will be applied instead.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Slides of the 2006 alveolar rhabdomyosarcoma (ARMS) TMA and the 2009 ARMS/anaplastic embryonal rhabdomyosarcoma (ERMS) TMA

• PAX3-FOXO1-positive tumors

• PAX7-FOXO1-positive tumors

• Fusion-negative tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Oncology Group	Monrovia	California	United States	91006-3776

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Frederick Barr, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01609803
• Other Study ID Numbers: ARST12B7; NCI-2012-01972; COG-ARST12B7
• First Posted: Jun 1, 2012
• Last Update Posted: May 18, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Rhabdomyosarcoma; Rhabdomyosarcoma, Embryonal

Study Results

No Results Posted as of May 18, 2016