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Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01609803
Enrollment
99
Registered
2012-06-01
Start date
2012-06-30
Completion date
2016-05-31
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Amplification and fusion status as a result of the 12q13-q14 amplification eventBaselineFisher'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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026