|No phase specified||Biomarker/Laboratory analysis, Tissue collection/Repository||Active||50 and under||NCI, Other||D9902|
NCI-2009-00502, IRS-D9902, CCG-B904, COG-D9902, CDR0000078602, POG-9153, U10CA024507, NCT00919269
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. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.
Further Study Information
I. 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.
II. Provide a repository for storage of tissue and other biological specimens collected by COG investigators from these patients.
III. Make these specimens available for approved projects by laboratory-based investigators.
IV. Collect clinical data on these patients who are not being treated on a COG therapeutic study.
V. 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.
VI. 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.
VII. Compare the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma.
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.
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Non-rhabdomyosarcoma soft tissue sarcoma
- 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
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Steve Skapek, MD||Principal Investigator|
|Saint Peter's University Hospital|
|Stanley Calderwood||Ph: 732-745-8600ext6163|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00919269
ClinicalTrials.gov processed this data on February 13, 2014
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