Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

NCT ID: NCT01609803

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Correlative studies

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

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick Barr, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Monrovia, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-01972

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-ARST12B7

Identifier Type: OTHER

Identifier Source: secondary_id

ARST12B7

Identifier Type: -

Identifier Source: org_study_id

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