Collect/Store Tissue, Blood & BM from Pts w/Soft Tissue Sarcomas

A COG soft tissue sarcoma diagnosis, biology, and banking protocol

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica

    Trial Phone: 321.841.3837

  • IRB No: D9902

    Principal Investigator: Vincent F. Giusti, MD

    Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Gray, Rachel PA-C; Kelly, Susan MD; Levy, Alex MD; Martin, Rebecca, ARNP; Pope, Michele ARNP; Smith, Amy MD; Story, Allison ARNP; Sullivan, Kelly ARNP; Sutphin, Robert MD; Wieber, Laura ARNP

    Age Group: Pediatric

    Secondary Protocol No: D9902

    Treatment: Non-Treatment

    Applicable Disease Sites: Sarcoma

    Therapies Involved: Other: biologic sample preservation procedure Other: laboratory biomarker analysis

    ClinicalTrials.gov ID: NCT00919269

  • Objective

    The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma.

  • Key Eligibility

    Eligibility

    Ages Eligible for Study: up to 50 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Sampling Method: Non-Probability Sample

    Study Population

    Patients planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study, patients planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study and patients NOT planning to be enrolled on a front-line COG RMS or NRSTS therapeutic study.

    Criteria


    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