Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma

This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00919269
First received: June 11, 2009
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

RATIONALE: Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.

PURPOSE: The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory.


Condition Intervention
Chordoma
Desmoid Tumor
Sarcoma
Genetic: reverse transcriptase-polymerase chain reaction
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: A COG Soft Tissue Sarcoma Biology and Banking Protocol

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma [ Designated as safety issue: No ]
  • Creation of a repository for storage of tissue and other biological specimens collected by COG investigators [ Designated as safety issue: No ]
  • Making these specimens available for approved projects by laboratory-based investigators [ Designated as safety issue: No ]
  • Collection of clinical data on patients who are not being treated on a COG therapeutic study [ Designated as safety issue: No ]
  • Definition and comparison of clinical features of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry the t(2;13), t(1;13) or neither translocation [ Designated as safety issue: No ]
  • Relationship between submicroscopic alveolar rhabdomyosarcoma disease and CR/PR rates, failure-free survival, survival by positive or negative RT-PCR assay for t(2:13) and t(1:13) on peripheral blood and bone marrow specimens at diagnosis [ Designated as safety issue: No ]
  • Comparison of the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma [ Designated as safety issue: No ]

Study Start Date: March 1999
Detailed Description:

OBJECTIVES:

  • Collect human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma diagnosed and/or treated at a Children's Oncology Group (COG) member institution.
  • Provide a repository for storage of tissue and other biological specimens collected by COG investigators from these patients.
  • Make these specimens available for approved projects by laboratory-based investigators.
  • Collect clinical data on these patients who are not being treated on a COG therapeutic study.
  • Define and compare the clinical features of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry the t(2;13), t(1;13) or neither translocation.
  • Investigate the relationship between evidence of submicroscopic disease and response rate (CR/PR), failure-free survival, and survival of patients with alveolar rhabdomyosarcoma, as determined by positive or negative reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the t(2:13) and t(1:13) on peripheral blood and bone marrow specimens obtained at diagnosis.
  • Compare the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma.

OUTLINE: Surgical tissue, bone marrow, and blood specimens are collected at diagnosis (initial or relapse) and, if applicable, at the development of a second primary tumor. Specimens are used for research purposes. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Patients who are not enrolled on a Children's Oncology Group treatment trial are followed every 6 months for at least 10 years or until disease progression or development of a second malignancy.

PROJECTED ACCRUAL: No projected accrual limit will apply to this study.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Rhabdomyosarcoma
    • Non-rhabdomyosarcoma soft tissue sarcoma

      • Chordoma
      • Desmoid fibromatosis
      • Desmoplastic round cell tumors
      • Undifferentiated embryonal sarcoma of the liver
    • Unclassified soft tissue sarcoma that is too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS")
    • Other soft tissue neoplasms, excluding benign tumors
  • Must have pathological specimens of tumor-containing tissue or bone marrow (beyond that needed by the institution for diagnosis) available for study
  • No malignant rhabdoid tumor, Ewing sarcoma/primitive neuroectodermal tumor, or osteogenic sarcoma of bone
  • No osteogenic sarcoma

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919269

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Steve Skapek, MD University of Chicago Comer Children's Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00919269     History of Changes
Other Study ID Numbers: CDR0000078602, COG-D9902, IRS-D9902, CCG-B904, POG-9153
Study First Received: June 11, 2009
Last Updated: November 22, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent adult soft tissue sarcoma
recurrent childhood soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
childhood desmoplastic small round cell tumor
chordoma
desmoid tumor

Additional relevant MeSH terms:
Chordoma
Rhabdomyosarcoma
Fibromatosis, Aggressive
Sarcoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on May 21, 2013