Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Amplification and fusion status as a result of the 12q13-q14 amplification event
Study Overview
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.
Detailed Description
PRIMARY OBJECTIVES:
I. 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
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Amplification and fusion status as a result of the 12q13-q14 amplification event
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported