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DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01419509
First received: August 17, 2011
Last updated: May 13, 2016
Last verified: May 2016
  Purpose

RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated.

PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.


Condition Intervention
Sarcoma
Genetic: DNA methylation analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Panel of hypermethylation assays for minimal disseminated RMS [ Designated as safety issue: No ]
  • Detection of RMS cells in bone marrow [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tumor, Blood, and Bone Marrow Samples

Estimated Enrollment: 170
Study Start Date: August 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To establish a panel of hypermethylation assays for minimal disseminated disease analysis in rhabdomyosarcoma (RMS).
  • To apply the hypermethylation assays to a series of bone marrow specimens from RMS patients.

OUTLINE: Archived tumor, bone marrow, and peripheral blood samples are analyzed for DNA hypermethylation by PCR-based assays and microarray assays. Results are then compared with each patient's clinical and pathological characteristics, and outcomes. Patterns of locus hypermethylation in tumor and paired bone marrow samples are also compared.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with rhabdomyosarcoma
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with rhabdomyosarcoma (RMS)
  • Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT01419509

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen R. Master, MD University of Pennsylvania
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01419509     History of Changes
Other Study ID Numbers: ARST11B1  COG-ARST11B1  ARST11B1  NCI-2011-02985 
Study First Received: August 17, 2011
Last Updated: May 13, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
mixed childhood rhabdomyosarcoma
pleomorphic childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
nonmetastatic childhood soft tissue sarcoma

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

ClinicalTrials.gov processed this record on September 30, 2016