Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01496573
First received: December 16, 2011
Last updated: May 7, 2015
Last verified: May 2015
  Purpose

This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor 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


Condition Intervention
Alveolar Childhood Rhabdomyosarcoma
Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational - CRKL Expression at the Protein Level in Rhabdomyosarcoma Tumors by Tissue Microarray (TMA)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • CRKL expression at the protein level [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor tissue


Estimated Enrollment: 77
Study Start Date: December 2011
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Basic science (biomarker analysis)
Archived tumor tissue samples are analyzed for CRKL expression.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).

OUTLINE:

Archived tumor tissue samples are analyzed for CRKL expression.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma

Criteria

Inclusion Criteria:

  • Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496573

Locations
United States, California
Children's Oncology Group Recruiting
Monrovia, California, United States, 91006-3776
Contact: Lee J. Helman, MD    301-496-4256    helmanl@nih.gov   
Principal Investigator: Lee J. Helman, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Lee Helman, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01496573     History of Changes
Other Study ID Numbers: ARST12B4, NCI-2012-00094
Study First Received: December 16, 2011
Last Updated: May 7, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Sarcoma

ClinicalTrials.gov processed this record on September 03, 2015