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

Completed

• Conditions: Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Rhabdomyosarcoma; Untreated Childhood Rhabdomyosarcoma; Desmoid-Type Fibromatosis; Metastatic Childhood Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma AJCC v7; Stage III Adult Soft Tissue Sarcoma AJCC v7; Childhood Desmoplastic Small Round Cell Tumor; Adult Rhabdomyosarcoma

• Registration Number: NCT00919269
• Lead Sponsor: Children's Oncology Group

Brief 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.

Detailed Description

PRIMARY 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.

Study Timeline

• Study Start: 1999-03-15
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma	Up to 10 years
Collection of clinical data on patients who are not being treated on a COG therapeutic study	Up to 10 years

Trial Locations

Locations (247)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Phoenix Childrens Hospital; 🇺🇸 Phoenix, Arizona, United States

The University of Arizona Medical Center-University Campus; 🇺🇸 Tucson, Arizona, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center; 🇺🇸 Downey, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

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