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Eligibility
for people ages up to 50 years
Location
at Oakland, California and other locations
Dates
study started
Principal Investigator
Carla B. Golden Robert E. Goldsby

Description

Summary

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.

Official Title

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Details

OBJECTIVES:

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.

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.

Keywords

Adult Rhabdomyosarcoma Childhood Desmoplastic Small Round Cell Tumor Chordoma Desmoid Tumor Metastatic Childhood Soft Tissue Sarcoma Nonmetastatic Childhood Soft Tissue Sarcoma Previously Treated Childhood Rhabdomyosarcoma Previously Untreated Childhood Rhabdomyosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma 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

Eligibility

For people ages up to 50 years

Inclusion Criteria:

  • 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

Locations

  • Kaiser Permanente-Oakland accepting new patients
    Oakland, California, 94611, USA
  • Lucile Packard Children's Hospital Stanford University accepting new patients
    Palo Alto, California, 94304, USA
  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento, California, 95817, USA
  • Children's Oncology Group accepting new patients
    Arcadia, California, 91006, USA
  • Southern California Permanente Medical Group accepting new patients
    Downey, California, 90242, USA
  • City of Hope Medical Center in progress, not accepting new patients
    Duarte, California, 91010, USA
  • Loma Linda University Medical Center accepting new patients
    Loma Linda, California, 92354, USA
  • Miller Children's Hospital accepting new patients
    Long Beach, California, 90806, USA
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles, California, 90027, USA
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, USA
  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles, California, 90095, USA
  • Mattel Children's Hospital UCLA accepting new patients
    Los Angeles, California, 90095, USA
  • Children's Hospital Central California accepting new patients
    Madera, California, 93636, USA
  • Childrens Hospital of Orange County accepting new patients
    Orange, California, 92868, USA
  • Rady Children's Hospital - San Diego accepting new patients
    San Diego, California, 92123, USA
  • Santa Barbara Cottage Hospital accepting new patients
    Santa Barbara, California, 93102, USA

Details

Status
accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00919269
Lead Scientists
Carla B. Golden
Robert E. Goldsby
Study Type
Observational
Last Updated
September 2016