Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma

May 17, 2016 updated by: Children's Oncology Group

Study Recurrency Testing of Mutations Identified in WGS of Pediatric Rhabdomyosarcoma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions.
  • To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma.

OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.

Study Type

Observational

Enrollment (Anticipated)

58

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with rhabdomyosarcoma

Description

DISEASE CHARACTERISTICS:

  • Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of particular genetic lesions
Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alberto S. Pappo, MD, St. Jude Children's Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARST12B3 (Other Identifier: Children's Oncology Group)
  • COG-ARST12B3 (Other Identifier: Children's Oncology Group)
  • CDR0000732173 (Other Identifier: Clinical Trials.gov)
  • NCI-2012-00729 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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